Identity
- Trade Name
- BZG FDA UDI
- Generic Name
- Cocaine/cocaine metabolite IVD, reagent FDA UDI
- Device Name
- The Cocaine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine (Cocaine Metabolite) in human urine. FDA UDI
- Model / Reference
- DA4011 FDA UDI
- Description
- The Cocaine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine (Cocaine Metabolite) in human urine. FDA UDI
Identifiers
- Catalog Number
- DA4011 FDA UDI
- Primary DI / UDI-DI
- 05055273208047 FDA UDI
- 510(k) Number
- K113751 FDA UDI
- FDA Product Code
- DIO FDA UDI
- GMDN Term
- Cocaine/cocaine metabolite IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
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
Category: Cocaine/cocaine metabolite IVD, reagent
Bzg by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 83ff6c99-b409-427d-8312-fd64b74e86c5 37 fields · synced Jun 6, 2026