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IMMULITE®/IMMULITE® 1000 Systems HsC High Sensitivity CRP
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- IMMULITE®/IMMULITE® 1000 Systems HsC High Sensitivity CRP FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, reagent FDA UDI
- Device Name
- CRP Cardiophase - IMMULITE - RGT - 100 Tests FDA UDI
- Model / Reference
- 10286287 FDA UDI
- Description
- CRP Cardiophase - IMMULITE - RGT - 100 Tests FDA UDI
Identifiers
- Catalog Number
- LKCRP1 FDA UDI
- Primary DI / UDI-DI
- 00630414963792 FDA UDI
- 510(k) Number
- K063057 FDA UDI
- FDA Product Code
- NQD 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
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
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, reagent
IMMULITE®/IMMULITE® 1000 Systems HsC High Sensitivity CRP by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
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
- CRP Reagent Set — CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Class II
- hsCRP — Randox Laboratories, Ltd. · Class II
- Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- CRP — Randox Laboratories, Ltd. · Class II
Cleared under the same submission
K063057 also covers:
- IMMULITE® 2000 Systems CRP CRP Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems hsC High Sensitivity CRP — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® Systems CRP CONTROL C-Reactive Protein — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE® 1000 Systems CRP Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI def89014-f7a3-4208-9d95-0a172e0db699 37 fields · synced May 30, 2026