Identity
- Trade Name
- CRP Reagent Kit FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Full Range C-Reactive Protein Reagent Kit for use with EasyRA Analyzers FDA UDI
- Model / Reference
- 10228-4 FDA UDI
- Description
- Full Range C-Reactive Protein Reagent Kit for use with EasyRA Analyzers FDA UDI
Identifiers
- Catalog Number
- 10228-4 FDA UDI
- Primary DI / UDI-DI
- 00386100002244 FDA UDI
- 510(k) Number
- K130080 FDA UDI
- FDA Product Code
- DCK FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, kit, spectrophotometry 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
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
Yes
FDA UDI
Category: C-reactive protein (CRP) IVD, kit, spectrophotometry
CRP Reagent Kit by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 HS CRP RGT KIT Pt No. ST645 — Carolina Liquid Chemistries Corp. · Class II
- HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT — BIOMERICA, INC. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
Cleared under the same submission
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
- Medica Corp.
Sources (1)
- FDA UDI 95d4e323-c8ae-4095-ab76-6d24d56ac431 37 fields · synced Jun 1, 2026