Identity
- Trade Name
- Identify Health FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Identify Health 8 Panel Drug Test Cup CLIA Waived - 3.0mm Test Strip AMP500, BUP10, BZO300, COC150, EDDP300, MET500, MOP300, OXY100 FDA UDI
- Model / Reference
- ID-H8-1 FDA UDI
- Description
- Identify Health 8 Panel Drug Test Cup CLIA Waived - 3.0mm Test Strip AMP500, BUP10, BZO300, COC150, EDDP300, MET500, MOP300, OXY100 FDA UDI
Identifiers
- Catalog Number
- ID-H8-1 FDA UDI
- Primary DI / UDI-DI
- 10850721007928 FDA UDI
- FDA Product Code
- DJC FDA UDIDKZ FDA UDIJXM FDA UDIDIO FDA UDIDJR FDA UDIDJG FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3610 FDA UDI862.3100 FDA UDI862.3170 FDA UDI862.3250 FDA UDI862.3620 FDA UDI862.3650 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 Health 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 693b9e4a-a742-4210-91a0-80c382006b7b 36 fields · synced May 30, 2026