Identity
- Trade Name
- Fluoro-CheckerTM TRF Reader FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, point-of-care FDA UDI
- Device Name
- Analyzer for Fluoro-CheckTM line of diagnostic products. FDA UDI
- Model / Reference
- TRF FDA UDI
- Description
- Analyzer for Fluoro-CheckTM line of diagnostic products. FDA UDI
Identifiers
- Catalog Number
- TF101 FDA UDI
- Primary DI / UDI-DI
- 00895160002403 FDA UDI
- GMDN Term
- Fluorescent immunoassay analyser IVD, point-of-care FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fluorescent immunoassay analyser IVD, point-of-care
Fluoro-CheckerTM TRF Reader by Nano-Ditech Corporation — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Nano-Ditech Corporation
Sources (1)
- FDA UDI d67df70c-cec6-4f21-9a13-25569e581067 35 fields · synced Jun 9, 2026