Genabio Diagnostics Inc. products

Intended use: iHealth® COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.

Intended Use: INDICAID™ COVID-19 Rapid Antigen Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first five (5) days of symptom onset. Anterior nasal swab specimens may be collected by a healthcare provider (HCP) or self-collected (by individuals 18 years of age or older, under the supervision of an HCP). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate complexity, high complexity, or waived tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

cIntended Use: Fosun COVID-19 RT-PCR Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) from individuals suspected of COVID-19 by their healthcare provider.

Intended use: Genabio® Molecular Panel for Vaginitis detects over 30 different pathogens that causes various vaginal symptoms or sexually transmitted diseases.

Intended use: Genabio Leukorrhea Panel is a multiplex PCR for simultaneous detection of Chlamydia trachomatis (C.trachomatis), Neisseria gonorrhoeae (N.gonorrhoeae) and Trichomonas vaginalis (T.vaginalis) in genital specimens from women.

Intended use: Genabio® Genital Ulcer Panel is a multiplex PCR assay for simultaneous detection of below mentioned three pathogens in clinical specimens. The three major causes of Genital Ulcer Disease (GUD) in the United States are Herpes simplex virus, Treponema pallidum (syphilis) and Haemophilus ducreyi (chancroid).

 

Intended Use: GONGDONG Vacuum Urine Collection Tube is mainly used for urine specimen collection and non-contamination operation before inspection.

Intended use: Wondfo® T-Square Oral Fluid Drug Test is a simple and convenient method of drug screening. Full observation during collection allows the testing to be performed anytime and anywhere, which greatly reduces the specimen-tampered concerns. Because it takes time for drug to metabolize and pass through body, oral fluid is also recognized as the optimal method for drug screening.

Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms.

The nitrile examination gloves are intended to be worn on the hands of healthcare personnel to prevent contamination between patients and examiners.