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Rapid Response

FDA UDI

Class II (US FDA UDI)

by BTNX Inc

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 Panels (THC/COC/OPI) - 25 tests/ kit are for the qualitative detection of Opiates, Cocaine and THC metabolites in urine. FDA UDI
Model / Reference
D3.2-1P29-25 FDA UDI
Description
Rapid Response Multi Drug Test Panels (THC/COC/OPI) - 25 tests/ kit are for the qualitative detection of Opiates, Cocaine and THC metabolites in urine. FDA UDI

Identifiers

Catalog Number
D3.2-1P29-25 FDA UDI
Primary DI / UDI-DI
00722066000779 FDA UDI
510(k) Number
K121065 FDA UDI
FDA Product Code
DJG FDA UDI
LDJ FDA UDI
DIO 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 UDI
862.3870 FDA UDI
862.3250 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

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 is a robust and reliable Enzyme Immunoassay for the qualitative detection of multiple drugs of abuse in urine, including Opiates, Cocaine, and THC metabolites. This rapid test is designed for clinical use and point-of-care analyses, with 25 tests per kit. The Rapid Response Multi Drug Test Panels are available in various commercial distributions.

Similar devices

Also classified as Multiple drugs of abuse IVD, kit, rapid ICT, clinical.

Cleared under the same submission

K121065 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BTNX Inc

Sources (1)

  • FDA UDI 596b8260-d831-4920-978f-3e3791432046 35 fields · synced Jul 20, 2026