Identity
- Trade Name
- CRP Control Set FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, control FDA UDI
- Device Name
- These CRP Controls Set are intended for use in CRP test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.2 For in vitro diagnostic use only. C-reactive protein (CRP) is described in the literature as an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. CRP is one of the most sensitive indicators of inflammation. FDA UDI
- Model / Reference
- L1 x 3 x 3mL, L2 x 3 x 3mL FDA UDI
- Description
- These CRP Controls Set are intended for use in CRP test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.2 For in vitro diagnostic use only. C-reactive protein (CRP) is described in the literature as an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. CRP is one of the most sensitive indicators of inflammation. FDA UDI
Identifiers
- Catalog Number
- 502-155 FDA UDI
- Primary DI / UDI-DI
- 00812137012159 FDA UDI
- FDA Product Code
- DCK FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, control 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
Yes
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, control
CRP Control Set by Clinical Diagnostic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Diazyme — Diazyme Laboratories, Inc.
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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 fe4ff2c0-c8e2-4959-bf03-9403de7ec326 36 fields · synced Jun 8, 2026