Identity
- Trade Name
- Nano-Check TM Strep A Test FDA UDI
- Generic Name
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- A lateral flow immunoassay for the qualitative detection of Strep A specific carbohydrate antigen from human throat swabs specimen collected from symptomatic patients to aid in the diagnosis of Group A Streptococcal infection FDA UDI
- Model / Reference
- MD8148 FDA UDI
- Description
- A lateral flow immunoassay for the qualitative detection of Strep A specific carbohydrate antigen from human throat swabs specimen collected from symptomatic patients to aid in the diagnosis of Group A Streptococcal infection FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00895160002687 FDA UDI
- GMDN Term
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- 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
Yes
FDA UDI
Category: Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Nano-Check TM Strep A Test by Nano-Ditech Corporation — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical.
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- 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
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Nano-Ditech Corporation
Sources (1)
- FDA UDI bbcda0c2-c5f5-42fa-bcdc-6db43ebeecd5 34 fields · synced Jun 9, 2026