Uni-Gold Strep a Test Kit
FDA 510(k) K982373 · Trinity Biotech, Plc
510(k) numberK982373
Submission
- Device name
- Uni-Gold Strep a Test Kit
- Applicant
- Trinity Biotech, Plc
Los Angeles, CA, US - Received
- July 7, 1998
- Decision date
- February 11, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GTY – Antigens, All Groups, Streptococcus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
Other 510(k)s with product code GTY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260342 | AllTest Strep A Rapid TestGTY · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 04/30/2026SE |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripGTY · Dual Track | ACON Laboratories, Inc. | 11/26/2025SE |
| K212623 | Healgen Strep A Rapid Test Strip (Throat Swab)GTY · Traditional | Healgen Scientific,, LLC | 03/16/2022SE |
| K171976 | Sofia Strep A+ FIA, Sofia 2 AnalyzerGTY · Dual Track | Quidel Corporation | 12/21/2017SE |
| K141775 | Sofia (R) Strep A+ FiaGTY · Dual Track | Quidel Corporation | 12/16/2014SE |
| K133343 | Wondfo Rapid Strep a TestGTY · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 01/31/2014SE |
| K123793 | Sofia Strep a FiaGTY · Traditional | Quidel Corporation | 06/17/2013SE |
| K122718 | BD Veritor(Tm) System for Rapid Detection of Group a StrepGTY · Traditional | Becton, Dickinson and Company | 02/06/2013SE |
| K091489 | Clearview Advanced Strep a , Model 737-430GTY · Traditional | Binax, Inc. | 09/04/2009SE |
| K082661 | Biostrep a, Biosign Strep a, Statusfirst Strep aGTY · Special | Princeton BioMeditech Corp. | 10/06/2008SE |
More from Princeton BioMeditech Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K172254 | Lyme B. burgdorferi (IgM) MarStripe TestLSR · Traditional | 10/23/2017SE |
| K163095 | Lyme B. burgdorferi (IgG) MarStripe TestLSR · Traditional | 02/01/2017SE |
| K120001 | Unigold GiardiaMHI · Traditional | 03/01/2013SE |
| K121565 | Uni-Gold CryptosporidiumMHJ · Traditional | 02/08/2013SE |
| K083896 | Destiny Max Coagulation AnalyzerJPA · Traditional | 07/02/2009SE |
| K033059 | Herpes Group IggLGC · Traditional | 11/26/2003SE |
| K014233 | Captiam Syphilis-G AssayLIP · Special | 01/24/2002SE |
| K011709 | Uni-Gold Strep a Test KitGTZ · Traditional | 11/08/2001SE |
| K001525 | Captia Syphilis-G Elisa Test SystemLIP · Traditional | 11/29/2000SE |
| K991697 | Uni-Gold H. PyloriLYR · Traditional | 12/21/1999SE |
Questions and answers
When was Uni-Gold Strep a Test Kit cleared by the FDA?
Uni-Gold Strep a Test Kit (K982373) received a 510(k) decision of Substantially Equivalent on February 11, 1999, 219 days after the submission was received.
What is the product code of K982373?
The FDA product code is GTY – Antigens, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.