Identity
- Trade Name
- CRP Reagent Set FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, reagent FDA UDI
- Device Name
- For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only. C-reactive protein (CRP) is an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. As such, CRP is considered to be one of the most sensitive indicators of inflammation. FDA UDI
- Model / Reference
- R1 x 50mL, R2 x 50mL FDA UDI
- Description
- For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only. C-reactive protein (CRP) is an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. As such, CRP is considered to be one of the most sensitive indicators of inflammation. FDA UDI
Identifiers
- Catalog Number
- 501-435 FDA UDI
- Primary DI / UDI-DI
- 00812137012098 FDA UDI
- FDA Product Code
- DCK FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, reagent 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
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
No
FDA UDI
Category: C-reactive protein (CRP) IVD, reagent
CRP Reagent Set by Clinical Diagnostic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-reactive protein (CRP) IVD, reagent.
- CRP — Randox Laboratories, Ltd. · Class II
- IMMUNEX CRP® — ALERE NORTH AMERICA, LLC · Class II
- K-ASSAY® hsCRP Reagent — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
- Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- hsCRP — Randox Laboratories, Ltd. · Class II
- Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- CRP — Randox Laboratories, Ltd. · Class II
- IMMULITE® 2000 Systems hsC High Sensitivity CRP — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · 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
- Clinical Diagnostic Solutions, Inc.
Sources (1)
- FDA UDI 6991c61d-38db-4f1b-b7f3-7ab815ed92fc 36 fields · synced May 30, 2026