Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Rapid Response Single Drug Test Cassette (MET) - 40 tests/ kit are for the qualitative detection of methamphetamine in urine. FDA UDI
- Model / Reference
- MET-1C2-40 FDA UDI
- Description
- Rapid Response Single Drug Test Cassette (MET) - 40 tests/ kit are for the qualitative detection of methamphetamine in urine. FDA UDI
Identifiers
- Catalog Number
- MET-1C2-40 FDA UDI
- Primary DI / UDI-DI
- 00722066000571 FDA UDI
- 510(k) Number
- K121065 FDA UDI
- FDA Product Code
- DJC FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3610 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 ebda8c09-4df6-4c71-8554-99419060e37f 35 fields · synced Jun 1, 2026