Identity
- Trade Name
- Nano-Check TM COVID-19 Antigen Test FDA UDI
- Generic Name
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2. Nano-Check™ COVID-19 Antigen Test is intended for use by medical professionals or operators who are proficient in performing tests. FDA UDI
- Model / Reference
- MD-8147 FDA UDI
- Description
- An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2. Nano-Check™ COVID-19 Antigen Test is intended for use by medical professionals or operators who are proficient in performing tests. FDA UDI
Identifiers
- Catalog Number
- MD-8147-20T FDA UDI
- Primary DI / UDI-DI
- 00895160002786 FDA UDI
- FDA Product Code
- QMN FDA UDIQLW FDA UDI
- GMDN Term
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing FDA UDI
Classification
- Device Class
- N 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
Yes
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: SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingSARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Nano-Check TM COVID-19 Antigen Test by Nano-Ditech Corporation — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 N | Pending data |
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Manufacturer
- Manufacturer
- Nano-Ditech Corporation
Sources (1)
- FDA UDI 49073bbf-ad92-44cf-886a-db1a2881beb5 35 fields · synced Jun 9, 2026