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CAROLINA LIQUID CHEMISTRIES CORP.® IgM Immunoglobulin IgM CC638
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- CAROLINA LIQUID CHEMISTRIES CORP.® IgM Immunoglobulin IgM CC638 FDA UDI
- Generic Name
- Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- IgM (Immunoglobulin M) 2 x 60 tests FDA UDI
- Model / Reference
- CC638 FDA UDI
- Description
- IgM (Immunoglobulin M) 2 x 60 tests FDA UDI
Identifiers
- Catalog Number
- CC638 FDA UDI
- Primary DI / UDI-DI
- 00817302020953 FDA UDI
- FDA Product Code
- CFF FDA UDI
- GMDN Term
- Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 FDA UDI
- Commercial Distribution
- Not 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 — 8 Milliliter FDA UDITotal Volume — 23 Milliliter FDA UDI
CAROLINA LIQUID CHEMISTRIES CORP.® IgM Immunoglobulin IgM CC638 by Carolina Liquid Chemistries Corp. — Class II — FDA UDI — listed in FDA GUDID
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 1db003e5-1227-4559-9961-8c6118dea626 38 fields · synced May 30, 2026