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Carolina Liquid Chemistries Corp.® Crpw Rgt. Kit Bl-645
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- CAROLINA LIQUID CHEMISTRIES CORP.® CRPW RGT. KIT BL-645 FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, spectrophotometry FDA UDI
- Device Name
- CRPhsWR (C-Reactive Protein high sensitivity Wide Range) 2 x 100 tests FDA UDI
- Model / Reference
- BL645 FDA UDI
- Description
- CRPhsWR (C-Reactive Protein high sensitivity Wide Range) 2 x 100 tests FDA UDI
Identifiers
- Catalog Number
- BL645 FDA UDI
- Primary DI / UDI-DI
- 00817302022063 FDA UDI
- FDA Product Code
- DCK FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, kit, spectrophotometry 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 15 Milliliter FDA UDITotal Volume — 10 Milliliter FDA UDI
Category: C-reactive protein (CRP) IVD, kit, spectrophotometry
Carolina Liquid Chemistries Corp.® Crpw Rgt. Kit Bl-645 by Carolina Liquid Chemistries Corp. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as C-reactive protein (CRP) IVD, kit, spectrophotometry.
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- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® CRPW RGT. KIT AU-645 — Carolina Liquid Chemistries Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 HS CRP RGT KIT Pt No. ST645 — Carolina Liquid Chemistries 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
- Carolina Liquid Chemistries Corp.
Sources (1)
- FDA UDI 22927194-158e-4eba-ae2a-809679883cdd 37 fields · synced Jun 8, 2026