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Carolina Liquid Chemistries Corp.® Rf Reagent Cc629
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- CAROLINA LIQUID CHEMISTRIES CORP.® RF REAGENT CC629 FDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- RF (Rheumatoid Factor) 2 x 160 tests FDA UDI
- Model / Reference
- CC629 FDA UDI
- Description
- RF (Rheumatoid Factor) 2 x 160 tests FDA UDI
Identifiers
- Catalog Number
- CC629 FDA UDI
- Primary DI / UDI-DI
- 00817302021004 FDA UDI
- FDA Product Code
- DHR FDA UDI
- GMDN Term
- Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5775 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 — 20 Milliliter FDA UDITotal Volume — 4 Milliliter FDA UDI
Category: Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)
Carolina Liquid Chemistries Corp.® Rf Reagent Cc629 by Carolina Liquid Chemistries Corp. — Class II — FDA UDI — listed in FDA GUDID
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- RF IgG (Rheumatoid Factor) ELISA — DRG International, Inc. · Class II
- Rheumatoid Factor IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- QUANTA Lite® CCP3 IgG ELISA Bulk Pack — INOVA DIAGNOSTICS, INC. · Class II
- Rheumatoid Factor IgA ELISA — DRG International, Inc. · 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 4c882438-f181-4ea4-ae9a-1203f462599f 37 fields · synced Jun 6, 2026