Identity
- Trade Name
- RaPET® CRP FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion FDA UDI
- Device Name
- Latex agglutination slide test for the Qualitative and Semi-quantitative determination of C-Reactive Protein in non-diluted serum. FDA UDI
- Model / Reference
- 1130-100 FDA UDI
- Description
- Latex agglutination slide test for the Qualitative and Semi-quantitative determination of C-Reactive Protein in non-diluted serum. FDA UDI
Identifiers
- Catalog Number
- 1130-100 FDA UDI
- Primary DI / UDI-DI
- 00657498001257 FDA UDI
- FDA Product Code
- DCN FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion
RaPET® CRP by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- C Reactive Protein RID plate package — KENT LABORATORIES, INC. · Class I
- ASI CRP Slide Test — Arlington Scientific, Inc. · Class II
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- Human C-Reactive Protein ‘EL’ NANORID Radial Immunodiffusion Kit — The Binding Site Group
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
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI 7b3c2bfc-2133-48d4-bf27-b537e6c280aa 36 fields · synced May 30, 2026