Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- D4.57-1VF- COC300 MET1000 AMP1000 OPI2000 FDA UDI
- Model / Reference
- D4.57-1VF FDA UDI
- Description
- D4.57-1VF- COC300 MET1000 AMP1000 OPI2000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10722066008123 FDA UDI
- 510(k) Number
- K180349 FDA UDI
- FDA Product Code
- NGL FDA UDINFT FDA UDINGG FDA UDINFY FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 FDA UDI862.3100 FDA UDI862.3610 FDA UDI862.3250 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
Yes
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
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 II | Pending data |
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Manufacturer
- Manufacturer
- BTNX Inc
Sources (1)
- FDA UDI 33f2d678-bf03-4a00-b1b0-9ac2887bfdef 34 fields · synced May 30, 2026