Identity
- Trade Name
- Poly stat FDA UDI
- Generic Name
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Strep A, Immunochromatographic, Flip FDA UDI
- Model / Reference
- STF25 FDA UDI
- Description
- Strep A, Immunochromatographic, Flip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855574005438 FDA UDI
- 510(k) Number
- K040708 FDA UDI
- FDA Product Code
- GTY FDA UDI
- GMDN Term
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3740 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
No
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 antigen IVD, kit, rapid ICT, clinical
Poly stat by Polymedco, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical.
- Clearview® — Alere San Diego, Inc. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- Icon — Beckman Coulter, Inc. · Class I
- Status Strep A Flip — PRINCETON BIOMEDITECH CORP. · Class I
- Status Strep A Flip — PRINCETON BIOMEDITECH CORP. · Class I
- Status Strep A Plus — PRINCETON BIOMEDITECH CORP. · Class I
- Accutest Value+ Strep A Rapid Test Strip — JANT PHARMACAL CORP. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
Cleared under the same submission
K040708 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Polymedco, Inc.
Sources (1)
- FDA UDI 3410ad6a-cc96-459d-92dd-867c6c812f04 35 fields · synced May 30, 2026