Home › Device types › PGX
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
FDA product code PGX · Class 2 · Microbiology
24
Registered devices
3
Adverse events
4
Recalls
14
510(k) clearances
Devices with this code
Alere i Strep A 2 — Alere Scarborough, Inc.AmpliVue — QUIDEL CORPORATIONSimplexa™ Group A Strep Positive Control Pack — DIASORIN MOLECULAR LLCBIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel — BIOFIRE DIAGNOSTICS, LLCBIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini — BIOFIRE DIAGNOSTICS, LLCcobas® Strep A Quality Control Kit for use on the cobas® Liat® System — Roche Molecular Systems, Inc.Alere™ i Strep A — Alere Scarborough, Inc.cobas® Strep A Nucleic acid test for use on the cobas® Liat® System — Roche Molecular Systems, Inc.cobas Liat Strep A Script Version 1.27 — Roche Molecular Systems, Inc.Solana — QUIDEL CORPORATIONARIES® Group A Strep Assay — LUMINEX CORPORATIONAlere i Strep A 2 Control Swab Kit — Alere Scarborough, Inc.cobas® Liat® Strep A Script — Roche Molecular Systems, Inc.GenePOC™ Strep A — GenePoc IncXpert Xpress Strep A — CEPHEIDRevogene® Strep A — Meridian Bioscience Canada IncSimplexa™ Group A Strep Direct — DIASORIN MOLECULAR LLCLyra — QUIDEL CORPORATIONID NOW Strep A 2 — Alere Scarborough, Inc.Solana — DIAGNOSTIC HYBRIDS, INC.Revogene Strep A — MERIDIAN BIOSCIENCE, INC.Alere™ i Strep A Control Swab Kit — Alere Scarborough, Inc.Xpert Xpress Strep A — CEPHEIDID NOW Strep A 2 Control Swab Kit — Alere Scarborough, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-04-24 | Cepheid | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results. |
| 2023-04-24 | Cepheid | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results. |
| 2019-02-20 | Luminex Corporation | Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, re |
| 2016-02-10 | Focus Diagnostics Inc | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL265 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.