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Carolina Liquid Chemistries Corp.® Apob Rgt. Kit Au-633
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- CAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT AU-633 FDA UDI
- Generic Name
- Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- APO B (Apolipoprotein B) 3 x 200 tests FDA UDI
- Model / Reference
- AU-633 FDA UDI
- Description
- APO B (Apolipoprotein B) 3 x 200 tests FDA UDI
Identifiers
- Catalog Number
- AU-633 FDA UDI
- Primary DI / UDI-DI
- 00817302020908 FDA UDI
- FDA Product Code
- DER FDA UDI
- GMDN Term
- Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5580 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 — 16 Milliliter FDA UDITotal Volume — 46 Milliliter FDA UDI
Category: Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Carolina Liquid Chemistries Corp.® Apob Rgt. Kit Au-633 by Carolina Liquid Chemistries Corp. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry.
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- ARCHITECT — Abbott · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
- Alinity — Abbott · Class II
- APO B — Randox Laboratories, Ltd. · Class I
- APO B — Randox Laboratories, Ltd. · Class I
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 595cf6ce-0a73-4f15-bac6-23e382aabd7e 37 fields · synced May 30, 2026