Panels › Microbiology › Product code GTY · Class 1
Antigens, All Groups, Streptococcus Spp.
Regulation 866.3740
2510(k)s in 12 months (44 all time)
4recalls in 12 months (20 all time)
8recalls that name a 510(k)
Top companies in GTY
| Company | 510(k)s | Recalls |
|---|---|---|
| Quidel Corp. | 5 | 2 |
| Wondfo USA Co Ltd | 0 | 5 |
| ACON Laboratories, Inc. | 4 | 0 |
| Princeton BioMeditech Corp. | 4 | 0 |
| Altruan GmbH | 0 | 3 |
| Sa Scientific, Inc. | 3 | 0 |
| Scientific Device Laboratory, Inc. | 3 | 0 |
| Abbott Laboratories | 2 | 0 |
| Alere San Diego | 0 | 2 |
| Biostar, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2026 | Quidel Corporation QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. Open, Classified |
GTY | K011097 |
| Mar 12, 2026 | Altruan GmbH Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs. Open, Classified |
GTY | None listed |
| Mar 12, 2026 | Altruan GmbH Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples. Open, Classified |
GTY | None listed |
| Mar 12, 2026 | Altruan GmbH Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection. Open, Classified |
GTY | None listed |
| Sep 10, 2025 | Quidel Corporation QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC Open, Classified |
GTY | K011097 |
| Aug 18, 2025 | Mckesson Medical-Surgical Inc. Corporate Office Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020 Open, Classified |
GTY | K010582 |
| Sep 19, 2024 | Cypress Medical Products LLC Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008 Open, Classified |
GTY | K010582 |
| Jun 7, 2024 | Wondfo USA Co Ltd Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, St Open, Classified |
GTY | None listed |
| Jun 7, 2024 | Wondfo USA Co Ltd Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC Open, Classified |
GTY | None listed |
| Jun 7, 2024 | Wondfo USA Co Ltd Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100 Open, Classified |
GTY | None listed |
| Jun 7, 2024 | Wondfo USA Co Ltd Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Num Open, Classified |
GTY | None listed |
| Jun 7, 2024 | Wondfo USA Co Ltd Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10 Open, Classified |
GTY | None listed |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Strep test:
a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003.
b. QUIDEL Open, Classified |
GTY | K010582 K141775 +1 |
| Aug 7, 2015 | Remel Inc PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap.
Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Group Terminated |
GTY | None listed |
| Aug 7, 2015 | Remel Inc PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit.
Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary cultur Terminated |
GTY | None listed |
| Feb 22, 2012 | Alere San Diego Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes.
Brand Name (Catalog Number): ACON Rapid Device Strep A Twist (IST-502T); CONSULT Diagnostics Strep A Twist, PSS (5005); Medi-Lab Terminated |
GTY | K023766 |
| Feb 22, 2012 | Alere San Diego Strep A Rapid Test Cassette (K031784), IST-502 Cassettes.
Brand Name (Catalog Number): Acceava Strep A Cassette (92004 E-Z); Accutest Integrated Strep A Rapid Test Device JANT (ID440); ACON Strep A Terminated |
GTY | K031784 |
| Aug 23, 2011 | Jay Bird Investments Inc @ Home Strep Test
Rapid Strep Test
Product Usage: For in-vitro diagnostic use - detection of Strep. Terminated |
GTY | None listed |
| Feb 22, 2011 | Biosite Inc Dba Innovacon Inc. SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037
The SP Brand Strep A Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from Terminated |
GTY | K031784 |
| Sep 22, 2008 | Mainline Technology, Inc. Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A streptococcal antigen directly from throat swabs, Mainline Technology, Inc., Ann Arbor, MI; Terminated |
GTY | None listed |
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