Identity
- Trade Name
- Pointe CRP Reagent FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Pointe CRP Reagent 4 x 60ml R1, 4 x 60ml R2. For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay using the Mindray BS-480 analyzer. FDA UDI
- Model / Reference
- 14-C7568-480 FDA UDI
- Description
- Pointe CRP Reagent 4 x 60ml R1, 4 x 60ml R2. For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay using the Mindray BS-480 analyzer. FDA UDI
Identifiers
- Catalog Number
- 14-C7568-480 FDA UDI
- Primary DI / UDI-DI
- 00811727015815 FDA UDI
- FDA Product Code
- DCK FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry 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
Yes
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, kit, nephelometry/turbidimetry
Pointe CRP Reagent by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry.
- CardioPhase® hsCRP — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- C-Reactive Protein Gen.3 — Roche Diagnostics Corp. · Class II
- Cardiac CReactive Protein Latex High Sensitive — Roche Diagnostics Corp. · Class II
- Alinity — Abbott Laboratories, Inc. · Class II
- Cardiac CReactive Protein Latex High Sensitive — Roche Diagnostics Corp. · Class II
- Tinaquant CReactive Protein Gen3 — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- CReactive Protein Latex) — Roche Diagnostics Corp. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI c15983ca-85f4-4e04-84d5-bb60bdd0f9f0 36 fields · synced Jun 1, 2026