Identity
- Trade Name
- DrugCheck FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- DrugCheck NxStep OnSite Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-TCA-THC FDA UDI
- Model / Reference
- 61210 FDA UDI
- Description
- DrugCheck NxStep OnSite Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-TCA-THC FDA UDI
Identifiers
- Catalog Number
- 61210 FDA UDI
- Primary DI / UDI-DI
- B2986121010 FDA UDI
- FDA Product Code
- LDJ FDA UDILFG FDA UDILCM FDA UDIDJG FDA UDIDJR FDA UDILAF FDA UDIDIO FDA UDIJXM FDA UDIDIS FDA UDIDKZ FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 FDA UDI862.3910 FDA UDI862.3650 FDA UDI862.3620 FDA UDI862.3610 FDA UDI862.3250 FDA UDI862.3170 FDA UDI862.3150 FDA UDI862.3100 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
No
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
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugCheck by Express Diagnostic Int'l, 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
- Express Diagnostic Int'l, Inc.
Sources (1)
- FDA UDI 7f353204-2e0f-4f8b-8264-942d6195df8e 36 fields · synced May 30, 2026