Search Results

For in vitro diagnostic use only. For use in the calibration of the VITROS ECVECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of insulin in human serum and plasma (Li Heparin).

The VITROS® Immunodiagnostic Products Insulin Calibrators contain three levels of calibrator, Calibrator 1, 2, 3. Nominal values are 1 uIU/mL, 25 µIU/mL and 250 µIU/mL respectively. The calibrators are liquid and comprised of recombinant human insulin in buffer containing BSA with an antimicrobial agent. VITROS® Immunodiagnostic Products Insulin Calibrators kit contains 1 vial of each calibrator 1, 2, and 3. Each vial contains 1mL of calibrator.

CalSet IGF-1 is used for calibrating the quantitative Elecsys IGF-1 assay on the Elecsys and cobas e immunoassay analyzers.

CalSet IGF-1 is used for calibrating the quantitative Elecsys IGF-1 assay on the Elecsys and cobas e immunoassay analyzers. CalSet IGF-1 is a two concentration level set of lyophilized human serum matrix that is traceable to the WHO IS 02/254 Reference Material. The CalSet includes: - IGF-1 Call: 2 bottles, each for 1.0 mL of calibrator 1 . - IGF-1 Cal2: 2 bottles, each for 1.0 mL of calibrator 2 . IGF-1 in two concentration ranges (approximately 20 ng/mL and approximately 500 ng/mL) in a human serum matrix.

The ARCHITECT Free T3 Calibrators are for the ARCHITECT i System when used for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.

The calibrators are devices intended for medical purposes for use in the ARCHITECT Free T 3 assay test system to establish points of reference that are used in the quantitative determination of values in the measurement of substances in human specimens. Free T3 measurements are used as an aid in the assessment of thyroid status. The calibrators are designed to be used on the ARCHITECT i System (i 2000gg, i 2000, and i 1000sR) with the ARCHITECT Free T3 Reagents. The ARCHITECT Free T3 Calibrator kit contains: ARCHITECT Free T3 Calibrator A contains human serum. Preservative: Sodium Azide. ARCHITECT Free T3 Calibrators B through F contain different concentrations of L-Thyroxine and L-Triiodothyronine prepared in human serum. Preservative: Sodium Azide.

Lumipulse G FSH-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G FSH-N on the LUMIPULSE G System.

Master calibration data are recorded in a two-dimensional bar code on the Lumipulse G FSH-N Immunoreaction Cartridge case. The calibration curve is created based on recorded master calibration data and the calibration data. The follicle-stimulating hormone (FSH) concentration of a specimen is automatically calculated from the calibration curve. The result of the calculation is reported in mIU/mL. Lumipulse® G FSH-N Calibrators: Lumipulse® G FSH-N Calibrators REF 230930 Each calibrator kit contains one bottle each of calibrators 1 - 2 and consists of the following: CAL 1 0 mlU/mL FSH calibrator (1 x 1.5 mL) CAL 2 250 mlU/mL FSH calibrator (1 x 1.5 mL) *Contains follicle-stimulating hormone (FSH) in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.

Lumipulse G Progesterone-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G Progesterone-N on the LUMIPULSE G System.

Lumipulse G Progesterone-N Calibrator kit contains 3 bottles (1.5 mL each) of Lumipulse G Progesterone-N Calibrators 1, 2, and 3. Calibrators 1, 2, and 3 contain progesterone in 0.15 M sodium chloride in MES buffer with protein (bovine) and chemical stabilizers. Preservative: sodium azide. Lumipulse G Progesterone-N Calibrators CAL 230893, Liquid 1x3 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 3. The calibrator kit is packaged separately. CAL 1 0 ng/mL Progesterone calibrator (1 × 1.5 mL) CAL 2 0.5 ng/mL Progesterone calibrator (1 x 1.5 mL) 40 ng/mL Progesterone calibrator (1 x 1.5 mL) CAL 3 *Contains progesterone in 0.15 M sodium chloride in MES buffer with protein (bovine) and chemical stabilizers. Preservative: sodium azide.

Lumipulse® GLH Calibrators are for in vitro diagnostic use in the calibration of Lumipulse GLH on the LUMIPULSE G System.

The Lumipulse® G LH Calibrator kit contains 2 bottles (1.5mL each) of Lumipulse® G LH Calibrators 1 and 2. Calibrators 1 and 2 contain luteinizing hormone (LH) in 0.15M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide. Lumipulse® G LH Calibrators CAL 230916, Liquid 1x2 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 2. The calibrator kit is packaged separately. CAL 1 0 mlU/mL LH calibrator (1 x 1.5 mL) CAL 2 250 mIU/mL LH calibrator (1 x 1.5 mL) *Contains luteinizing hormone (LH) in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide The Lumipulse® G LH calibrator set is designed specifically for use on the LUMIPULSE® G System which has been previously cleared under k142895.

Lumipulse G Prolactin Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G Prolactin on the LUMIPULSE G System.

Lumipulse G Prolactin Calibrator kit contains 2 bottles (1,5 mL each) of Lumipulse G Prolactin Calibrators 1 and 2. Calibrator 2 contains prolactin in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide. Lumipulse® G Prolactin Calibrators CAL 230954, Liquid 1x2 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 2. The calibrator kit is packaged separately. CAL 1 0 ng/mL Prolactin calibrator (1 x 1.5 mL) CAL 2 400 ng/mL Prolactin calibrator (1 x 1.5 mL) Contains prolactin in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.

For IN VITRO diagnostic use as a calibrator in clinical chemistry assays for UIBC (Unsaturated Iron Binding Capacity). DC-UIBC-CAL may be used to check the linearity over the reportable patient range of UIBC assays.

DC-UIBC-CAL is a human based, lyophilized serum intended for use as a calibrator with Sekisui Diagnostics UIBC Assays. The concentrations and activities of the UIBC (Unsaturated Iron Binding Capacity) is optimized for the calibration of clinical chemistry systems - Beckman Coulter AU® Systems, Roche/Hitachi® Beckman Coulter SYNCHRON® Systems, and Cobas Mira®. The DC-UIBC-CAL kit consists of the following: Six vials with 10mL of lyophilized serum. Human serum was used in the manufacture of this product. The human serum in this product has been prepared exclusively from the blood of donors tested individually and shown by FDAapproved methods to be free from HBsAg and antibodies to HCV and HIV. However, as no test method can rule out the potential risk of infection with absolute certainty, the material should be treated just as carefully as a patient sample. In the event of exposure, the directives of the responsible Health Authorities should be followed.

Lumipulse & E2-III Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G E2-III on the LUMIPULSE® G System.

The Lumipulse G E2-III Calibrator kit contains 3 bottles (1.5mL each) of Lumipulse G E2-III Calibrators 1, 2 and 3. Calibrators 1 – 3 contain estradiol in 0.15M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide. Lumipulse G E2-III Calibrators CAL 233849. Liquid 1x3 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 3. The calibrator kit is packaged separately. CAL 1 E2 calibrator 1 (1 × 1.5 mL) E₂ calibrator 2 (1 x 1.5 mL) CAL 2 CAL 3 E2 calibrator 3 (1 × 1.5 mL) *Contains 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide. The calibrator values vary for each lot. The actual values are printed on the calibration card included in the kit.

The ADVIA Centaur® Insulin (IRI) Master Curve Material (MCM) is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur® Insuin assay. The ADVIA Centaur® Insulin (IRI) Calibrator is for in vitro diagnostic use in calibrating the ADVIA Centaur® systems Insulin assays.

ADVIA Centaur® Insulin (IRI) Master Curve Material is a set of ten vials of material containing various levels of insulin in buffered saline with casein, potassium thiocyanate (3.89%), sodium azide (<0.1%), and preservatives. Each set contains ten levels (MCM1-10); ready-to-use 1.0 mL per level. MCM1 contains no analyte. The IRI MCMs assigned values are lot-specific of target values: 0.0, 2.5, 4.5, 10.0, 20.0, 39.0, 79.0, 158, 225, and 330 mU/L. ADVIA Centaur® Insulin (IRI) Calibrator is a set of four vials (two vials of low calibrator and two vials of high calibrator) comprised of buffered saline, with casein, potassium thiocyanate, sodium azide and preservative. Only the high calibrator contains insulin.