Identity
- Trade Name
- ID NOW Strep A 2 FDA UDI
- Generic Name
- Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- A rapid, automated, molecular test for the qualitative detection of Streptococcus pyogenes Group A bacterial nucleic acid in throat swab specimens. FDA UDI
- Model / Reference
- 734-000 FDA UDI
- Description
- A rapid, automated, molecular test for the qualitative detection of Streptococcus pyogenes Group A bacterial nucleic acid in throat swab specimens. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877010552 FDA UDI
- FDA Product Code
- PGX FDA UDIOOI FDA UDI
- GMDN Term
- Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.2680 FDA UDI862.2570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
ID NOW Strep A 2 by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT).
- Revogene Strep A — MERIDIAN BIOSCIENCE, INC. · Class II
- Solana — Quidel Corp. · Class II
- cobas® Strep A Nucleic acid test for use on the cobas® Liat® System — Roche Molecular Systems, Inc. · Class II
- Xpert Xpress Strep A — CEPHEID · Class II
- Alethia™ Group A Streptococcus — MERIDIAN BIOSCIENCE, INC. · Class II
- Xpert Xpress Strep A — CEPHEID · Class II
- Simplexa™ Group A Strep Direct — DiaSorin Molecular LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI 6890f4f7-c38e-4047-966d-1f1bba7e8331 33 fields · synced Jun 8, 2026