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K-ASSAY® CRP (Ver.2) is intended to be used for the quantitative determination of C-reactive protein (CRP) in human serum and plasma (potassium-EDTA or lithium-heparin) by immunoturbidimetric assay. Measurement of CRP aids in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. FOR IN VITRO DIAGNOSTIC USE.

The K-ASSAY® CRP (Ver.2) assay quantifies C-reactive protein based on immunoturbidimetric assay. The reagent uses latex combined with goat polyclonal antibody specific to human CRP. By adsorbing CRP in the sample to the surface of the latex particles and reacting it with the anti-CRP antibody, specific aggregation corresponding to the CRP concentration occurs. Since the absorbance of the reaction changes in proportion to the amount of aggregation, the concentration of CRP in the sample is determined based on the calibration curve prepared using a standard of known CRP concentrations. The K-ASSAY® CRP (Ver.2) assay can be run using a chemistry analyzer. 6 levels of calibrators from the K-ASSAY® CRP Calibrator (Ver.2) calibrators are used for quantifying the levels of CRP present in the patient's sample.

The Procise CRP assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of C-Reactive Protein (CRP) levels in human serum. The test is carried out by means of the ProciseDx Analyzer. Measurement of CRP aids in evaluation of injury to body tissues, inflammatory disorders. The instrument and assay are for use by trained professionals in the clinical laboratory. For in vitro diagnostic use only. Not for point of care use.

The Procise CRP assay is a homogeneous sandwich immunoassay assay that uses a fluorescence resonance energy transfer (FRET) signal to detect and quantify CRP. FRET is a process in which a donor molecule, in an excited state, transfers excitation energy to an acceptor fluorophore when the two are brought into close proximity. Upon excitation at a characteristic wavelength the energy absorbed by the donor is transferred to the acceptor, which in turn emits light energy. The level of light emitted from the acceptor fluorophore is directly proportional to the degree of donor/acceptor complex formation. The Procise CRP assay format is designed as a competitive format. A monoclonal anti-CRP antibody and exogenous CRP antigen are labeled with donor and acceptor fluorophores, respectively. The monoclonal antibody specific for CRP is labelled with the donor fluorophores and the CRP antigen is labelled with the acceptor fluorophore. Similar to other competitive assay formats, as the concentration of CRP increases a proportional decrease in the signal is observed.

Yumizen C1200 CRP reagent is intended for the quantitative in vitro diagnostic determination of the C-reactive protein in human serum and lithium heparin plased on an immunoturbidimetric assay. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues and for evaluation of infections, tissue injury and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings.

Yumizen C1200 CRP (Licensed for USP6, 248, 597/ USP6, 828, 158 and equivalent patents in other countries) is a latex-enhanced immunoturbidimetric assay developed to accurately measure CRP levels in serum and plasma samples for conventional CRP ranges. When an antigen-antibody reaction occurs between CRP in a sample and anti-CRP antibody which has been sensitized to latex particles, agglutination results. This agglutination is detected as an absorbance change, with the magnitude of the change being proportional to the quantity of CRP in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration. Reagents Yumizen C1200 CRP is ready-to-use. Reagent 1: Buffer solution: Glycine buffer solution Reagent 2: Latex suspension: 0.20% w/v suspension of latex particles sensitized with anti-CRP antibodies (rabbit) After measurements are taken, reagent cassettes should remain in the refrigerated tray. Care should be taken not to interchange the caps with others cassettes. Reagents with different lot numbers should not be interchanged or mixed. This submission consists of the Yumizen C1200 CRP (1300023877) reagent for serum and plasma testing for Yumizen C1200 reagent CRP, the submission includes the controls Yumizen C1200 Level 1 Protein Control (1300023944) and Yumizen C1200 Level 2 Protein Control (1300023945) for use on Yumizen C1200 Analyzer. The submission for Yumizen C1200 reagent CRP also includes the corresponding calibrator Yumizen C1200 CRP Cal (1300023899) for use on Yumizen C1200 Analyzer.

The CRP Vario assay [CRPVa] is for in vitro diagnostic use in the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma (sodium and lithium heparin) using the ARCHITECT c Systems. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders. CRP Calibrators (including CRP Calibrator Set, CRP Calibrator HS and CRP Calibrator WR) are intended to be used for the calibration of the CRP Vario for the quantitative determination of C-reactive protein in human serum or plasma samples.

The CRP Vario assay is intended for the quantitative immunoturbidimetric determination of C-reactive protein in human serum and plasma. It is supplied as a two-reagent kit. The kit contains Reagent 1 (Glycine buffer) and Reagent 2 (Anti-CRP polyclonal antibodies adsorbed on latex particles). Two different sizes of the product are available. The submission also describes CRP Calibrators (CRP Calibrator Set, CRP Calibrator HS, and CRP Calibrator WR) which are prepared by diluting CRP with human serum and stabilized by adding sodium azide.

Yumizen C1200 CRP reagent is intended for use as a high sensitive assay for the quantitative in vitro diagnostic determination of the C-reactive protein in human serum and plasma based on an immunoturbidimetric assay. CRP is used to evaluate conditions thought to be associated with inflammation in otherwise healthy individuals.

Yumizen C1200 CRP reagent is intended for use as a high sensitive assay for the quantitative in vitro diagnostic determination of the C-reactive protein in human serum and plasma based on an immunoturbidimetric assay.

For in vitro diagnostic use only. Rx Only. VITROS Chemistry Products hsCRP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure C-reactive protein (CRP) in human serum and plasma. CRP is used to evaluate conditions thought to be associated with inflammation in otherwise healthy individuals.

The quantitative measurement of C-reactive protein (CRP) is performed using the VITROS Chemistry Products hsCRP Reagent in conjunction with the VITROS Chemistry Products Calibrator Kit 17 and VITROS Chemistry Products FS Calibrator 1 on the VITROS 5,1 FS/4600 Chemistry System and the VITROS 5600 Integrated System. The VITROS Chemistry Products hsCRP Reagent is a dual chambered package containing ready-to-use liquid reagents. Samples, calibrators and controls are mixed with Reagent 1 containing a buffer. Addition of anti-CRP antibodies coupled to latex microparticles (Reagent 2) produces an immunochemical reaction yielding CRP antigen/antibody complexes. The turbidity is measured spectrophotometrically at 660 nm. Once a calibration has been performed for each reagent lot, the CRP concentration in each unknown sample can be determined using the stored calibration curve and the measured absorbance obtained in the assay of the sample.

QuikRead go® CRP: The QuikRead go® CRP test is an immunoturbidimetric assay for the in vitro quantitative determination of C-reactive protein (CRP) in K2-EDTA and lithium heparin whole blood, K2-EDTA and lithium heparin plasma and in serum samples. The test is carried out by means of the QuikRead go® instrument. Measurement of C-reactive protein aids in the evaluation of injury to body tissues, and inflammatory disorders. The instrument and assay are for use by trained professionals in the clinical laboratory. For in vitro diagnostic use only. Not for point-of-care use. QuikRead go® CRP Control Set: The QuikRead go® CRP Control Set is intended for use as assayed quality-control material for monitoring the performance of the quantitative QuikRead go® CRP assay with the QuikRead go® Instrument. For in vitro diagnostic use. QuikRead go® CRP Verification Set: The QuikRead go® CRP Verification Set is designed to be used for calibration verification and for method validation of the QuikRead go® CRP system. This assayed verification material is intended for use with the QuikRead go® CRP test and the QuikRead go® instrument. For in vitro diagnostic use. QuikRead go® Instrument: The Orion Diagnostica QuikRead go® is an in vitro diagnostic test system. The QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent kits. Not for point-of-care use.

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VITROS Chemistry Products CRP Slides: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/5.1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. C-reactive protein is synthesized by the liver and is one of the acute phase response, increased concentrations of a number of plasma proteins, including CRP, are observed. CRP concentration measurements are useful in the detection and evaluation of inflammatory disorders, tissue injury, and infections. VITROS Chemistry Products Calibrator Kit 7: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 7 is used to calibrate VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CRP.

The VITROS CRP Slide method is performed using the VITROS CRP Slides and the VITROS Chemistry Products Calibrator Kit 7 on VITROS Chemistry and Integrated Systems. The VITROS CRP Slide is a multilayered, analytical element coated on a polyester support. The immuno-rate format for CRP is based on an enzymatic heterogeneous, sandwich immunoassay format. In this format a derivative of phosphorylcholine (PC) is covalently bound to polystyrene polymer beads and in the presence of calcium serves as a capture agent. Monoclonal anti-CRP antibody conjugated to horseradish peroxidase (HRP) serves as a signal generator. A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. CRP in the sample binds to PC-linked capture beads and anti-CRP antibody labeled with horseradish peroxidase to form an insoluble sandwich complex in Incubation 1. The subsequent addition of 12 microliters of VITROS Immuno-Wash Fluid to the slide removes unbound materials from the read area, while also providing the hydrogen peroxide required for the enzyme-mediated oxidation of leuco dye. The reflection density of the dye is measured after the addition of VITROS Immuno-Wash Fluid at the end of Incubation 2. This reflection density is directly proportional to the concentration of CRP in the sample. To determine if an adequate wash has occurred, the wash detection dye is read at 540 nm immediately after Incubation 2. The VITROS Calibrator Kit 7 is prepared from processed human serum to which purified human C-reactive protein, inorganic salts, and preservatives have been added. The human blood products provided as components of VITROS Calibrator Kit 7 have been tested at the individual donor level and found nonreactive for hepatitis B surface antigen (HBsAg), antibody to HCV, and antibody to HIV using FDA approved methods.

FastPack® High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack® High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack® Analyzer. Not intended for Point-of-Care use. FastPack® High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer. FastPack® High Sensitivity C-Reactive Protein Controls are used for quality control of the FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer. FastPack® High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification of calibration and assay range of the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.

The FastPack® High Sensitivity C-Reactive Protein Immunoassay employs a Sandwich immunoassay principle. Endogenous CRP in a patient sample, calibrator, control, or verifier is dispensed into a FastPack® reagent pack. In the reagent pack, the sample binds with a monoclonal anti-CRP antibody covalently linked to alkaline phosphatase (ALP) and a different monoclonal anti-CRP antibody linked to biotin. After incubation, immunoreacted complex (Monoclonal anti-CRP antibody-ALP conjugate and anti-CRP antibody linked to biotin reacted with CRP in the sample) is mixed with streptavidin coated paramagnetic particles. After washing steps (using a Tris buffer containing detergents) to separate bound from unbound anti-CRP monoclonal antibody-ALP, a chemiluminogenic substrate mixture is added to the system. This mixture contains indoxyl-3-phosphate, a substrate for ALP, and lucigenin (N,N'-dimethyl-9,9'-biacridinium dinitrate). ALP dephosphorylates indoxyl-3-phosphate to indol-3-ol, which subsequently undergoes oxidation. As a result, lucigenin is reduced to form a dioxetane structure that is cleaved to yield Nmethylacridone. This compound produces a sustained luminescent glow following excitation. The raw relative luminescence units (RLUs) generated are measured by a photomultiplier tube in the FastPack® Analyzer and are directly proportional to the concentration of CRP in the sample. The entire reaction sequence takes place at 37 ± 0.5 ℃ and is protected from external light.

The Diazyme high sensitivity C-reactive protein (hsCRP) POC Test Kit is for the in vitro quantitative determination of C-reactive protein (CRP) in human venous whole blood on SMART analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only. The Diazyme hsCRP POC control set is intended for use as quality controls for the Diazyme hsCRP POC Test Kit. For in vitro diagnostic use only.

Diazyme's hsCRP POC Test Kit is based on a latex enhanced immunoturbidimetric assay on Diazyme's SMART analyzer. Agglutination occurs when an antigen-antibody reaction occurs between CRP in a sample and anti-CRP which has been sensitized to latex particles. This agglutination is detected as an absorbance change (700 nm), with the magnitude of the change being proportional to the quantity of CRP in the sample. The instrument calculates the CRP concentration of patient specimen by use of a lot specific calibration curve that is stored in an RFID card provided with each hsCRP POC kit. The RFID card is inserted in the SMART analyzer and is needed for every single run. Diazyme hsCRP POC Control Kit is intended for use as quality controls for the Diazyme hsCRP POC Test Kit and is packaged separately. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. OC materials are run exactly as samples. Users are instructed to verify the calibration curve with the controls and run controls each time a new lot of reagents are received. If OC materials fall outside laboratory acceptable range, users are instructed to re-test and call manufacturer customer service if problem persists. SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuvette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 20ul of sample to the DRS cuvette prefilled with R1 containing proper amount of detergent for whole blood lysis. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve. The Diazyme hsCRP POC Test Kit system thus consists of the following: - hsCRP POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and . cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer. - hsCRP POC Control Kit. Controls are provided for quality control of the . hsCRP POC Assay. Equipment needed for Diazyme hsCRP POC Test Kit: • SMART Analyzer (K092911). Kit components (Candidate device) Reagent 1 40 DRS cuvette (prefilled) - · 100 mM TrisCl buffer Reagent 2 40 DRS caps (prefilled) - Suspension of anti-human CRP polyclonal antibody coated latex particles . (< 0.5%). Calibrator 1 x preprogrammed lot specific RFID card in each kit 1 Control Set l x 1.0 mL Control 1 l x 1.0 mL Control 2