Identity
- Trade Name
- Fluoro-CheckTM CRP Test FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- A in vitro diagnostic test for the quantitative determination of C-reactive protein as an aid in the detection and evaluation of infection, tissue injury, inflammation, and associated diseases. FDA UDI
- Model / Reference
- TF3163 FDA UDI
- Description
- A in vitro diagnostic test for the quantitative determination of C-reactive protein as an aid in the detection and evaluation of infection, tissue injury, inflammation, and associated diseases. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00895160002670 FDA UDI
- FDA Product Code
- DCN FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5270 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
Yes
FDA UDI
Category: C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Fluoro-CheckTM CRP Test by Nano-Ditech Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-reactive protein (CRP) IVD, kit, fluorescent immunoassay.
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- ichroma Reader — Boditech Med, Inc. · Class II
- C-Reactive Protein HS ELISA — DRG International, Inc. · Class II
- ichroma™ CRP — Boditech Med, Inc. · 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
- Nano-Ditech Corporation
Sources (1)
- FDA UDI aeb4f9b0-35a7-4d26-a5c3-4fa01f75d157 34 fields · synced Jun 9, 2026