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Carolina Liquid Chemistries Corp.® Op Rgt. Kit Au-411a
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- CAROLINA LIQUID CHEMISTRIES CORP.® OP RGT. KIT AU-411A FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- OP (Opiates) FDA UDI
- Model / Reference
- AU-411A FDA UDI
- Description
- OP (Opiates) FDA UDI
Identifiers
- Catalog Number
- AU-411A FDA UDI
- Primary DI / UDI-DI
- 00817302021578 FDA UDI
- FDA Product Code
- DJG FDA UDI
- GMDN Term
- Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 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 — 23 Milliliter FDA UDITotal Volume — 60 Milliliter FDA UDI
Category: Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
Carolina Liquid Chemistries Corp.® Op Rgt. Kit Au-411a by Carolina Liquid Chemistries Corp. — Class II — FDA UDI — listed in FDA GUDID
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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 a29c39c7-d0bf-4948-af86-80e29a769b07 37 fields · synced Jun 8, 2026