QMedix™ - QMedix™ 5-Drug RapiDip InstaTest (OPI/COC/PCP/MET/THC)
2026-09-30
Diagnostic Automation, Inc.
GUDID#
AccuDiag™ T3 ELISA Kit - AccuDiag™ T3 ELISA KitA collection of reagents and other associated materials intended to be used for the quantitative measurement of total triiodothyronine (TT3) in a clinical specimen, using an enzyme immunoassay.
2026-03-02
AccuDiag™ Mycoplasma pneumoniae IgG ELISA - AccuDiag™ Mycoplasma pneumoniae IgG ELISAThe ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. The test may aid in the determination of the patient’s serological status or may aid in the diagnosis of disease associated with Mycoplasma pneumoniae.
2026-03-02
AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA - AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA KitA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple extractable nuclear antigens (ENA) in a clinical specimen
2026-02-27
AccuDiag™ Prolactin (PRL) ELISA - AccuDiag™ Prolactin (PRL) ELISAA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of prolactin in a clinical specimen, using an enzyme immunoassay (EIA) method.
2026-01-30
AccuDiag™ LH ELISA - AccuDiag™ (Luteinizing hormone ) LH ELISA
2026-01-30
AccuDiag™ Progesterone ELISA - AccuDiag™ Progesterone ELISAA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of progesterone in a clinical specimen, using an enzyme immunoassay (EIA) method.
2026-01-30
QMedix™ - QMedix™ ANA Screen ELISA
2024-04-23
AccuDiag™ Insulin ELISA - AccuDiag™ Insulin ELISAA collection of reagents and other associated materials intended to be used for the quantitative measurement of insulin in a clinical specimen, using an enzyme immunoassay (EIA) method.
2026-01-27
AccuDiag™ Human Growth Hormone (HGH) ELISA - AccuDiag™ Human Growth Hormone (HGH) ELISAA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human growth hormone (HGH) in a clinical specimen, using an enzyme immunoassay (EIA) method.
2026-01-27
AccuDiag™ C-Peptide ELISA Kit - AccuDiag™ C-Peptide ELISA KitA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-peptide in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used in the evaluation of insulin levels as an aid in the diagnosis of hypoglycaemia and insulinoma.
2026-01-27
AccuDiag™ Estradiol ELISA - AccuDiag™ Estradiol ELISA KitA collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen hormone estradiol in a clinical specimen, using an enzyme immunoassay (EIA) method.
2026-01-27
AccuDiag™ FSH ELISA - DACD4224-15
2026-01-27
AccuDiag™ Free Estriol ELISA - AccuDiag™ Free Estriol ELISA A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free estriol (oestriol) in a clinical specimen, using an enzyme immunoassay (EIA) method.
2026-01-27
AccuDiag™ 17-alpha-OH Progesterone ELISA - AccuDiag™ 17-alpha-OH Progesterone ELISAA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of 17-hydroxyprogesterone in a clinical specimen, using an enzyme immunoassay (EIA) method
2026-01-27
AccuDiag™ ANST (Androstenedione) ELISA - DACD1038-15
2026-01-27
QMedix™ - QMedix™ LH Ovulation Urine RapiCard™ InstaTest
2025-12-24
QMedix™ - QMedix™ hCG Combo Urine/Serum/Plasma RapiDip™ InstaTest
2025-12-24
Diagnostic Automation, Inc. - Stat Fax 2100 Microplate Reader
2025-12-24
Diagnostic Automation, Inc. - Stat Fax 2600 Microplate Washer
2025-12-24
QMedix™ - QMedix™ LH Ovulation Urine RapiCard™ InstaTest
2025-12-24
QMedix™ - QMedix™ hCG Combo Urine/Serum/Plasma RapiDip™ InstaTest
2025-12-24
QMedix™ - QMedix™ Benzodiazepines Urine RapiDip InstaTestA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of benzodiazepine in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test].
2025-12-23
QMedix™ - QMedix™ Benzodiazepines Urine RapiCard InstaTestA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of benzodiazepine in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test].
2025-12-23
QMedix™ - QMedix™ Benzodiazepines Urine RapiDip InstaTest A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of benzodiazepine in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test].
2025-12-23
QMedix™ - QMedix™ Benzodiazepines Urine RapiCard InstaTest A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of benzodiazepine in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test].
2025-12-23
QMedix™ - QMedix™ Measles IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibodies to Measles (Rubeola) virus in human sera.
2025-06-05
QMedix™ - QMedix™RF Latex Test Kit: The product is a latex agglutination slide test for the qualitative and semi quantitative in vitro determination of Rheumatoid Factor in serum.
2025-03-27
AccuDiag™ - AccuDiag™ TSH ELISA -A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen, using an enzyme immunoassay (EIA) method.
2024-11-14
QMedix™ - QMedix™ FTA-ABS (Syphilis) IFA Kit 10x10 wellsA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum in a clinical specimen using a fluorescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
2024-11-14
QMedix™ - QMedix™URS-10 InstaTest is intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period of time.
2024-10-29
QMedix™ - QMedix™ URS-1P is intended semi-quantitative and qualitative detection of protein in urine.
2024-10-29
QMedix™ - QMedix™ Herpes Simplex 1,2 IgM (HSV 1,2 IgM) ELISA is an enzyme-linked immunosorbent assay for the qualitative detection of IgM class antibodies to Herpes Simplex Virus (HSV) in human serum. This test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV and is for In Vitro diagnostic use.
2024-06-25
QMedix™ - QMedix™ hCG Combo Urine/Serum RapiCard™ InstaTest is used for the qualitative and/or (semi-)quantitative detection of total human chorionic gonadotropin (HCG),
2024-06-25
AccuDiag ™ - AccuDiag ™ H. pylori Antigen ELISAIntended to be used for the qualitative and/or quantitative detection of antigens from Helicobacter pylori bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.
2024-05-23
QMedix™ - QMedix™ EBV VCA IgG ImmunoFlourescent Assay
2024-05-23
AccuDiag™ - AccuDiag™ Anti-Phospholipid Screen IgG/IgM ELISA
2024-05-10
QMedix™ - QMedix™ Fecal Occult Blood RapiCard™ InstaTest
2024-05-10
AccuDiag ™ - AccuDiag™ TSH Ultra-Sensitive ELISA
2024-03-27
AccuDiag ™ - AccuDiag™ Echinococcus IgG ELISA
2024-03-27