Identity
- Trade Name
- Identify Health Drug Testing Device Test Cups FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Identify Health, 13 Panel Drug Screen Test Cup, CLIA Waived (AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, OPI300, OXY100, PCP25, TCA1000, THC50) Contents: Test Cups - 25, Package Insert - 1, Security Seals - 25, For In Vitro Diagnostics Use FDA UDI
- Model / Reference
- ID-H13-1 FDA UDI
- Description
- Identify Health, 13 Panel Drug Screen Test Cup, CLIA Waived (AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, OPI300, OXY100, PCP25, TCA1000, THC50) Contents: Test Cups - 25, Package Insert - 1, Security Seals - 25, For In Vitro Diagnostics Use FDA UDI
Identifiers
- Catalog Number
- ID-H13-1 FDA UDI
- Primary DI / UDI-DI
- 01085072100710 FDA UDI
- FDA Product Code
- DJG FDA UDILDJ FDA UDIDIO FDA UDIDKZ FDA UDIDJC FDA UDILCM FDA UDIJXM FDA UDIDIS FDA UDILFG 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
- 862.3650 FDA UDI862.3870 FDA UDI862.3250 FDA UDI862.3100 FDA UDI862.3610 FDA UDI862.3170 FDA UDI862.3150 FDA UDI862.3910 FDA UDI862.3620 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
Identify Health Drug Testing Device Test Cups by Medical Distribution Group Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 fd160771-fe11-41d1-9961-7e1112957978 36 fields · synced Jun 1, 2026