Identity
- Trade Name
- QuickProfile™ Drugs of Abuse Panel 5 Test FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / PCP / THC FDA UDI
- Model / Reference
- 07RD7064-01 FDA UDI
- Description
- Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / PCP / THC FDA UDI
Identifiers
- Catalog Number
- 07RD7064-01 FDA UDI
- Primary DI / UDI-DI
- M90107RD7064010 FDA UDI
- FDA Product Code
- LCM FDA UDIDJG FDA UDILDJ FDA UDIDKZ FDA UDIDIO FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 862.3650 FDA UDI862.3870 FDA UDI862.3100 FDA UDI862.3250 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
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
Dimensions & Sizes
- Size
- Length — 75 Millimeter FDA UDI
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QuickProfile™ Drugs of Abuse Panel 5 Test by LumiQuick Diagnostics, Inc. — Class U — 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 U | Pending data |
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Manufacturer
- Manufacturer
- LumiQuick Diagnostics, Inc.
Sources (1)
- FDA UDI a9a2d3eb-9fff-4899-a1e3-76aa93aa0845 37 fields · synced Jun 9, 2026