Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Rapid Response Multi Drug Test Panel (AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/TCA/THC) - 25 tests/ kit are for qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Methadone, Opiates, Phencyclidine, Tricyclic Antidepressant, Cocaine and THC metabolites in urine. FDA UDI
- Model / Reference
- D10.1-1P29-25 FDA UDI
- Description
- Rapid Response Multi Drug Test Panel (AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/TCA/THC) - 25 tests/ kit are for qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Methadone, Opiates, Phencyclidine, Tricyclic Antidepressant, Cocaine and THC metabolites in urine. FDA UDI
Identifiers
- Catalog Number
- D10.1-1P29-25 FDA UDI
- Primary DI / UDI-DI
- 00722066000847 FDA UDI
- 510(k) Number
- K121065 FDA UDI
- FDA Product Code
- LFG FDA UDILDJ FDA UDIDKZ FDA UDIDIS FDA UDIJXM FDA UDIDIO FDA UDIDJC FDA UDIDJR FDA UDIDJG FDA UDILCM FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3910 FDA UDI862.3870 FDA UDI862.3100 FDA UDI862.3150 FDA UDI862.3170 FDA UDI862.3250 FDA UDI862.3610 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
Yes
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
Rapid Response by BTNX Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121065 also covers:
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
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
- BTNX Inc
Sources (1)
- FDA UDI 629e659c-e85b-44b4-8658-f5f97b9eae0f 35 fields · synced Jun 1, 2026