Identity
- Trade Name
- Optilite High Sensitivity C-Reactive Protein Kit FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- LK044.L.OPT.A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700020152 FDA UDI
- 510(k) Number
- K180099 FDA UDI
- FDA Product Code
- DCN 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
Optilite High Sensitivity C-Reactive Protein Kit by The Binding Site Group — 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.
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- 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 |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (1)
- FDA UDI b8bc527a-2b29-4447-b31c-175f44ea911a 35 fields · synced Jun 1, 2026