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The Innovita Flu A/B Antigen Rapid Test is a rapid chromatographic immunoassay intended for the qualitative detection and differentiation of influenza A and B viral nucleoprotein antigens directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The test is intended for use as an aid in the differential diagnosis of acute influenza A and B viral infections. The test is not intended to detect influenza C antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the December 2023, and July 2024 influenza season when influenza A/H1N1pdm09, influenza A/H3N2 and influenza B/Victoria viruses were the predominant influenza viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If an infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The Innovita Flu A/B Antigen Rapid Test is a double antibody sandwich immunoassay-based test. The test device consists of the specimen zone and the test zone. The specimen zone contains monoclonal antibody against the Flu A/Flu B antigen labeled with latex microspheres and chicken IgY antibody conjugated with latex microspheres. The test line contains the other monoclonal antibody against Flu A/Flu B antigen. The control line contains rabbit anti-chicken IgY antibody. After the specimen is applied into the specimen well of the device, antigen in the specimen forms an immune complex with the binding reagent in the specimen zone. Then the complex migrates to the test zone. The test line in the test zone contains antibody from a specific pathogen. If the concentration of the specific antigen in the specimen is higher than LoD of Flu A or Flu B, it will be captured at Flu A or Flu B line and form a red-purple line. In contrast, if the concentration of the specific antigen is lower than LoD, it will not form a red-purple line. The test also contains an internal control system. A red-purple control line (C) should always appear after the test is completed. Absence of a red-purple control line indicates an invalid result. The product contents are listed below. | Contents | Amount | Description | |----------|--------|-------------| | Test cassette | 25 | Each sealed foil pouch containing one test device and one desiccant | | Extraction diluent | 25 | Vials with 500microliters of solution, mainly composed of Tris-HCl buffer (pH8.4), NaCl and Triton X-100. | | Swab | 25 | Nasopharyngeal swab | | Influenza A Positive Control | 1 | Swab is coated with non-infectious recombinant influenza A antigen | | Influenza B Positive Control | 1 | Swab is coated with non-infectious recombinant influenza B antigen | | Negative Control | 1 | Swab contains inactivated Staphylococcus aureus | | Package Insert | 1 | | | Quick Reference | 1 | |

An addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

The product is a kind of addition-cure silicon rubber impression material composed of vinyl polysiloxane and various fillers with neutral smell and applicable to impression in dentistry. This product is mainly composed of a matrix and a catalyst. The matrix is mainly composed of polydimethylsiloxane, vinyl silicone oil, methyl hydrogen polysiloxane, silica dioxide, ,calcium carbonate, and colorants. The catalyst is mainly composed of polydimethylsiloxane, silica dioxide, calcium carbonate, platinum catalyst, and colorants.

WLX & Bio Human Lubricant is a water based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

WLX & Bio Human Lubricant is a non-sterile, water-based, clear gel personal lubricant. It is a Class II medical device classified under 21 CFR 884.5300 (condom) and product code NUC (lubricant, personal). It contains Water, Glycerin, Propylene Glycol, Carbomer, Hydroxyethylcellulose, Triethanolamine, and Phenoxyethanol. The lubricant is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The lubricant is packaged in polyethylene (PE) bottles of 100 mL capacity (Model -WLX100).

Innovita HCG Pregnancy Rapid Combo Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).

The Innovita HCG Pregnancy Rapid Combo Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test device is used as a single cassette device.

Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3/Level 4 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices; provided sterile.

Disposable Surgical Gown

The Oral Matrix is intended for use in extraction sockets only to contain or prevent migration of graft material. The device is supplied sterile and intended for one time use.

The Oral Matrix consists of layered sheets of bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). These sheets are freeze-dried, packaged in a Tyvek pouch, and sterilized using ethylene oxide to achieve a SAL of 10-6. The Oral Matrix is available in eighteen different models, the differences between the models are shown in the table below. | Model | Size (cm) | Tolerance | Thickness | |--------------------|-----------|-----------|-------------| | SIS-ORP-4L-1×1 | 1×1 | | | | SIS-ORP-4L-2×2 | 2×2 | | | | SIS-ORP-4L-2×3 | 2×3 | | | | SIS-ORP-4L-3×3 | 3×3 | | | | SIS-ORP-4L-4×3 | 4×3 | | | | SIS-ORP-4L-6×6 | 6×6 | | | | SIS-ORP-4L-1.5×1.5 | 1.5×1.5 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-3×5 | 3×5 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-2.5×1.5 | 2.5×1.5 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-5×4 | 5×4 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-4×6 | 4×6 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-7×7 | 7×7 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-3×3.5 | 3×3.5 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-3×7 | 3×7 | ±0.2cm | 0.05~0.13mm | | SIS-ORP-4L-4×4 | 4×4 | | | | SIS-ORP-4L-5×5 | 5×5 | | | | SIS-ORP-4L-6×8 | 6×8 | | | | SIS-ORP-4L-8×8 | 8×8 | | |

Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gowns meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices; provided non-sterile.

Disposable Isolation Gown is designed for the medical personnel using in medical environment, not intended for use in the operating room. The employed material is a polypropylene and polyethylene (PP+PE) compound non-woven fabric. The color of the gown is blue. The gown has long sleeves with cuffs and neck fasten belts. There are seam tapes above the sleeves and where the sleeves meet the body. The seam tape is ethylene-vinyl acetate (EVA). The material of cuff is polyester and it is elastic. The body and sleeve of the Disposable Isolation Gowns are constructed from a blue PP+PE compound non-woven fabric and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a Disposable Isolation Gown. The Disposable Isolation Gown is a single use, disposable medical device.

The MEDICAL SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The MEDICAL SURGICAL MASK is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

The subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the facemask is to allow the user to fit the facemask around their nose, which is made of polyethylene coated iron wire. The mask will be provided in black and blue color, the colorant for the model JM92B is Carbon black (CAS No.1333-86-4), and for the model JM92 is Pigment Blue 15 (CAS No.147-14-8). The model JM92 will be provided in blue and labeled in Level 3, the model JM92B will be provided in black and labeled in Level 1.

The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile. Serial number: ZZ-YYKZ-01, size 175x95mm, Blue ZZ-YYKZ-02, size 145x95mm, Blue ZZ-YYKZ-03.size 175x95mm, Black ZZ-YYKZ-04, size 145x95mm, Black

The proposed device, Surgical Mask is a three-layer, plane bandage type mask with ear strap and nose clip. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The proposed device includes masks in two colors and two sizes, as shown in Table 1. The device is single use and provided sterile.

3N Contact Lenses Adjunct Cleaner is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses with only either OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution or Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution.

The proposed device, 3N Contact Lenses Adjunct Cleaner, Model TN083 is an electrical cleaner which is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses using approved contact lens solutions. The 3N Contact Lenses Adjunct Cleaner adopt the principle of protein electrophoresis, take advantage of the characteristics that negatively charged protein in certain environment and swarm towards positive pole in electric field, then the tear protein will be removed from the surface and air holes of contact lens and absorbed by anodic cleaning probe to achieve the goal of cleaning contact lenses. The cleaning components of the 3N Contact Lenses Adjunct Cleaner (Model: TN083) consist of a cleaning unit (Power Base) and a partitioned fluid reservoir functioning as the cleaning chamber. The cleaning chamber is detachably connected to the cleaning unit (power base). In the cleaning chamber, there are two independent cleaning tanks; and there is a cleaning probe on each side of the cleaning tank, namely electrode. In the cleaning unit, the circuit board is fixedly provided with electrode connectors electrically connected to the circuit board. The end of the electrode connector can be stretched and elastically connected with the bottom of the electrode.