FDA Product Code
FDA Product Code PGX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.2680
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) | Roche Molecular Systems, Inc. | 2026-08-28 | Traditional | PDF ↗ |
| K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | Diasorin Molecular, LLC | 2026-06-15 | Dual Track | PDF ↗ |
| K201269 | Accula Strep A Test | Mesa Biotech, Inc. | 2020-11-09 | Dual Track | PDF ↗ |
| K183366 | GenePOC Strep A | Genepoc, Inc. | 2019-03-06 | Traditional | PDF ↗ |
| K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit | Alere Scarborough, Inc. | 2018-05-02 | Dual Track | PDF ↗ |
| K173398 | Xpert Xpress Strep A | Cepheid | 2018-04-26 | Dual Track | PDF ↗ |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | Luminex Corporation | 2017-10-30 | Traditional | PDF ↗ |
| K172126 | Xpert Xpress Strep A | Cepheid | 2017-09-25 | Traditional | PDF ↗ |
| K162274 | Solana Strep Complete Assay | Quidel Corporation | 2016-10-25 | Traditional | PDF ↗ |
| K150868 | Solana GAS Assay, Solana instrument | Quidel Corporation | 2015-06-23 | Traditional | PDF ↗ |
| K141757 | ALERE I STREP A | Alere Scarborough, Inc. | 2015-03-31 | Traditional | PDF ↗ |
| K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack | Focus Diagnostics, Inc. | 2015-03-18 | Traditional | PDF ↗ |
| K141338 | LIAT STREP A ASSAY | Iquum, Inc. | 2014-11-04 | Traditional | PDF ↗ |
| K141173 | AMPLIVUE GAS ASSAY | Quidel Corporation | 2014-07-24 | Traditional | PDF ↗ |
| DEN140005 | LYRA DIRECT STREP ASSAY | Quidel Corporation | 2014-04-16 | Post-NSE | — |
Product code PGX · Class II · Microbiology. Data: openFDA.