Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Rapid Response 10 Panel Saliva Test Cup E/I Screening (D10.3.2-2FC1E)- THC40, COC20, OPI40, AMP50, MET50, BAR50, BZO10, MDMA50, MTD30, PPX50. For employment and insurance testing. FDA UDI
- Model / Reference
- D10.3.2-2FC1E FDA UDI
- Description
- Rapid Response 10 Panel Saliva Test Cup E/I Screening (D10.3.2-2FC1E)- THC40, COC20, OPI40, AMP50, MET50, BAR50, BZO10, MDMA50, MTD30, PPX50. For employment and insurance testing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10722066006624 FDA UDI
- FDA Product Code
- PVI FDA UDIPUX FDA UDIPUY FDA UDIPUZ FDA UDIPVA FDA UDIPVB FDA UDIPVD FDA UDIPVE FDA UDIPVF FDA UDIPVK FDA UDIPVJ FDA UDIPVG FDA UDIPVH FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3700 FDA UDI862.3100 FDA UDI862.3150 FDA UDI862.3170 FDA UDI862.3250 FDA UDI862.3270 FDA UDI862.3610 FDA UDI862.3620 FDA UDI862.3630 FDA UDI862.3910 FDA UDI862.3870 FDA UDI862.3640 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
No
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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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 db5042e6-7906-40aa-88b6-69d8b485c1d5 33 fields · synced Jun 7, 2026