Identity
- Trade Name
- Identify Diagnostics USA FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- (Identify USA - Drug Test Cups) / 6 Panel CLIA Waived Cup - BUP10, BZO300, COC150, MTD300, MOR300, OXY100 3mm Strip - 25 Pack Box FDA UDI
- Model / Reference
- ID-US6-BUP FDA UDI
- Description
- (Identify USA - Drug Test Cups) / 6 Panel CLIA Waived Cup - BUP10, BZO300, COC150, MTD300, MOR300, OXY100 3mm Strip - 25 Pack Box FDA UDI
Identifiers
- Catalog Number
- ID-US6-BUP FDA UDI
- Primary DI / UDI-DI
- 10850013035141 FDA UDI
- FDA Product Code
- JXM FDA UDIDIO FDA UDIDJG FDA UDIDJR FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3170 FDA UDI862.3250 FDA UDI862.3650 FDA UDI862.3620 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
No
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
Yes
FDA UDI
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify Diagnostics USA by Medical Distribution Group Inc — 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
- Medical Distribution Group Inc
Sources (1)
- FDA UDI 292d09d4-fef3-4be5-995c-2ff5c75d1e50 36 fields · synced Jun 1, 2026