Identity
- Trade Name
- POINTE SCIENTIFIC CRP Standard Set (2.5, 10, 20, 80, 160 mg/L) FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, calibrator FDA UDI
- Device Name
- The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set is intended to be used for the calibration of the manufacturer’s CRP (High Sensitivity) Wide Range immunoturbidimetric assay. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- C7568-STD FDA UDI
- Description
- The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set is intended to be used for the calibration of the manufacturer’s CRP (High Sensitivity) Wide Range immunoturbidimetric assay. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- C7568-STD FDA UDI
- Primary DI / UDI-DI
- 00811727011053 FDA UDI
- 510(k) Number
- K030545 FDA UDI
- FDA Product Code
- DCK FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, calibrator 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
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, calibrator
POINTE SCIENTIFIC CRP Standard Set - 10 by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — 6 models — regulatory data on deviCERTS
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Also classified as C-reactive protein (CRP) IVD, calibrator.
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- ABX Pentra CRP HS Cal — Horiba Abx · Class II
- CRP CAL — Randox Laboratories, Ltd. · Class II
- CRP CAL — Randox Laboratories, Ltd. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- hsCRP CAL — Randox Laboratories, Ltd. · Class II
- Alinity — Abbott Laboratories, Inc. · Class II
Cleared under the same submission
K030545 also covers:
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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI e4917e25-a4e2-46da-8fd2-4e89ac1e9de3 36 fields · synced May 30, 2026