Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Alinity c CRP Vario Reagent Kit 3500 CRP HS Tests, 2900 CRP WR Tests FDA UDI
- Model / Reference
- 07P5621 FDA UDI
- Description
- Alinity c CRP Vario Reagent Kit 3500 CRP HS Tests, 2900 CRP WR Tests FDA UDI
Identifiers
- Catalog Number
- 07P5621 FDA UDI
- Primary DI / UDI-DI
- 00380740180331 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
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, kit, nephelometry/turbidimetry
Alinity by Abbott Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Tinaquant CReactive Protein Gen3 — Roche Diagnostics Corp. · Class II
- CReactive Protein Latex) — Roche Diagnostics Corp. · Class II
- Yumizen C1200 CRP — Horiba Abx · Class II
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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
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI 2d5fd782-0e2e-4e10-8e8e-86f65acb88ca 36 fields · synced Jun 6, 2026