Profile: Diagnostic Test Group, LLC is a manufacturer and distributor of laboratory diagnostic products. We offer clarity urinalysis, clarity strep tests, clarity pregnancy (hCG) tests, fecal occult tests, cholesterol & glucose tests and clarity follicle stimulating hormone tests. Our clarity urinalysis reagent strips (urine) are used for the qualitative and semi quantitative detection of analytes in urine such as ascorbic acid, glucose, bilirubin, ketone, specific gravity, protein, urobilinogen, nitrite and leukocytes. The clarity urinalysis reagent strips (urine) are ideal for single use in professional near-patient (point-of-care) and centralized laboratory locations. Clarity strep A test strip contains a membrane coated with rabbit anti group A streptococcus antibody for the test line and a second control antibody and a conjugate pad impregnated with the rabbit anti-strep A antibody-dye complex. Clarity strep A is a rapid immunochromatographic assay for the qualitative detection of group A streptococcal antigen directly from throat swabs. Clarity strep A involves the chemical extraction of group A streptococcal antigen followed by solid-phase immunoassay technology for the detection of extracted antigen. In the test procedure, a throat swab specimen is collected, placed into a mixture of reagent A and B, and extracted for 1-2 minutes.

FDA Registration Number: 3004043187

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• Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR / 862.1645) A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

• Urine Leukocyte Test (FDA Code: LJX / 864.7675) A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.