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 Integrated Split Specimen Cup (AMP,BAR,BZO,COC,MET,MTD,OPI,PCP,TCA,THC) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Barbiturates, Benzodiazepines, Methadone, Opiates, Phencyclidine, Tricyclic-Antidepressant, Cocaine and THC metabolites in urine. FDA UDI
- Model / Reference
- D10.1-1G29-25 FDA UDI
- Description
- Rapid Response Multi Drug Integrated Split Specimen Cup (AMP,BAR,BZO,COC,MET,MTD,OPI,PCP,TCA,THC) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Barbiturates, Benzodiazepines, Methadone, Opiates, Phencyclidine, Tricyclic-Antidepressant, Cocaine and THC metabolites in urine. FDA UDI
Identifiers
- Catalog Number
- D10.1-1G29 FDA UDI
- Primary DI / UDI-DI
- 00722066000908 FDA UDI
- FDA Product Code
- LCM FDA UDILFG FDA UDIDIS FDA UDIJXM FDA UDIDIO FDA UDILDJ FDA UDIDJG FDA UDIDJR FDA UDIDJC FDA UDIDKZ FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 862.3910 FDA UDI862.3150 FDA UDI862.3170 FDA UDI862.3250 FDA UDI862.3870 FDA UDI862.3650 FDA UDI862.3620 FDA UDI862.3610 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
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 U — 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
K180349 also covers:
- Discover — AMERICAN SCREENING, L.L.C.
- Discover — AMERICAN SCREENING, L.L.C.
- Discover — AMERICAN SCREENING, L.L.C.
- Discover — AMERICAN SCREENING, L.L.C.
- Discover — AMERICAN SCREENING, L.L.C.
- Discover — AMERICAN SCREENING, L.L.C.
- Discover — AMERICAN SCREENING, L.L.C.
- Discover — AMERICAN SCREENING, L.L.C.
- Discover — AMERICAN SCREENING, L.L.C.
- Discover Plus — AMERICAN SCREENING, L.L.C.
- Discover Plus — AMERICAN SCREENING, L.L.C.
- Discover Plus — AMERICAN SCREENING, L.L.C.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BTNX Inc
Sources (1)
- FDA UDI 5d26c7db-23d3-47e0-be88-bda75f67a230 35 fields · synced May 30, 2026