Identity
- Trade Name
- C-Reactive Protein HS ELISA FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- The C-Reactive Protein HS ELISA is intended for the quantitative determination of C-reactive protein (CRP) in human serum. Enhanced sensitivity measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. FDA UDI
- Model / Reference
- EIA-3954 FDA UDI
- Description
- The C-Reactive Protein HS ELISA is intended for the quantitative determination of C-reactive protein (CRP) in human serum. Enhanced sensitivity measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. FDA UDI
Identifiers
- Catalog Number
- EIA-3954 FDA UDI
- Primary DI / UDI-DI
- 00840239039545 FDA UDI
- FDA Product Code
- DCK 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
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 50 Milliliter FDA UDITotal Volume — 12 Milliliter FDA UDITotal Volume — 1 Milliliter FDA UDITotal Volume — 11 Milliliter FDA UDI
Category: C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
C-Reactive Protein HS ELISA by DRG International, Inc. — 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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- C-Reactive Protein HS ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- ichroma Reader — Boditech Med, 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
- DRG International, Inc.
Sources (1)
- FDA UDI 59ad9cbe-8b05-4bd9-817d-d80870eaa11d 36 fields · synced May 30, 2026