ClearanceBrief
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)
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Top companies in GTY

DateFirm and productCodeLinked 510(k)
May 12, 2026Quidel Corporation
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Open, Classified
GTYK011097
Mar 12, 2026Altruan GmbH
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Open, Classified
GTYNone listed
Mar 12, 2026Altruan GmbH
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Open, Classified
GTYNone listed
Mar 12, 2026Altruan GmbH
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Open, Classified
GTYNone listed
Sep 10, 2025Quidel Corporation
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Open, Classified
GTYK011097
Aug 18, 2025Mckesson Medical-Surgical Inc. Corporate Office
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Open, Classified
GTYK010582
Sep 19, 2024Cypress Medical Products LLC
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
Open, Classified
GTYK010582
Jun 7, 2024Wondfo 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
GTYNone listed
Jun 7, 2024Wondfo 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
GTYNone listed
Jun 7, 2024Wondfo 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
GTYNone listed
Jun 7, 2024Wondfo 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
GTYNone listed
Jun 7, 2024Wondfo USA Co Ltd
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
Open, Classified
GTYNone listed
Aug 26, 2022Mckesson 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
GTYK010582
K141775 +1
Aug 7, 2015Remel 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
GTYNone listed
Aug 7, 2015Remel 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
GTYNone listed
Feb 22, 2012Alere 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
GTYK023766
Feb 22, 2012Alere 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
GTYK031784
Aug 23, 2011Jay Bird Investments Inc
@ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use - detection of Strep.
Terminated
GTYNone listed
Feb 22, 2011Biosite 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
GTYK031784
Sep 22, 2008Mainline 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
GTYNone listed

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