FDA.reportPublic FDA data

Rapid Response

Primary DI
10722066011277
Brand
Rapid Response
Company
BTNX Inc
Model
D12.49-1VAF
Device description
D12.49-1VAF Internal Code: D12.49-1VAF-TU - OXY100 BZO300 MOR300 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 FYL1+ OXI/CRE/PH
Published
2026-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NFVTest, Benzodiazepine, Over The Counter
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter
NGMTest, Phencyclidine (Pcp), Over The Counter
PTGTest, Methadone, Over The Counter
PTHTest, Barbiturate, Over The Counter
QAWTest, Tricyclic Antidepressants, Over The Counter
QBFTest, Propoxyphene, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2
NGMTest, Phencyclidine (Pcp), Over The CounterUnknownU
PTGTest, Methadone, Over The CounterClinical Toxicology2
PTHTest, Barbiturate, Over The CounterClinical Toxicology2
QAWTest, Tricyclic Antidepressants, Over The CounterClinical Toxicology2
QBFTest, Propoxyphene, Over The CounterClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20722066011274PackageGS1100In Commercial Distribution
10722066011277PrimaryGS10
00722066011270Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2072206601127420722066011274
1072206601127710722066011277
00722066011270007220660112707220660112700722066011270

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
251005005
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10722066018009Rapid ResponseD13.5-1VA2026-07-14
10722066015053Rapid ResponseD12.49-1VAF2026-05-15
10722066015084Rapid ResponseD13.5-1VF2026-05-15
10722066011260Rapid ResponseD13.5-1VF2026-01-19
20722066011267Rapid ResponseD13.5-1VF2026-01-19
20722066011274Rapid ResponseD12.49-1VAF2026-01-19
10722066011338Rapid ResponseFOB-9C36FOB-9C362026-01-02
20722066011335Rapid ResponseFOB-9C36FOB-9C362026-01-02
00722066000205Rapid ResponseHCG-3C50HCG-3C502016-10-25
00722066000267Rapid ResponseHCG-3C25HCG-3C252016-10-25
00722066004548Rapid ResponseD12.5-1V2019-01-21
10722066009083Rapid ResponseD12.49-1VA2025-10-03
10722066010973Rapid ResponseD13.5-1V2025-07-08
00722066010976Rapid ResponseD13.5-1V2025-07-08
10722066009601Rapid ResponseCOF-19CGHU22025-05-29
10722066009618Rapid ResponseCOF-19CGHU42025-05-29
10722066010751Rapid ResponseSTR-15SGPU-252025-05-29
10722066009595Rapid ResponseCOF-19CGHU12025-05-29
00722066009604Rapid ResponseCOF-19CGHU22025-05-29
00722066009611Rapid ResponseCOF-19CGHU42025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10722066018009Rapid ResponseBTNX IncQAW2026-07-14
10722066018009Rapid ResponseBTNX IncQBF2026-07-14
10722066018009Rapid ResponseBTNX IncNFV2026-07-14
10722066018009Rapid ResponseBTNX IncNFW2026-07-14
10722066018009Rapid ResponseBTNX IncNFY2026-07-14
10722066018009Rapid ResponseBTNX IncNGG2026-07-14
10722066018009Rapid ResponseBTNX IncNGL2026-07-14
10722066018009Rapid ResponseBTNX IncNGM2026-07-14
10722066018009Rapid ResponseBTNX IncPTG2026-07-14
10722066018009Rapid ResponseBTNX IncPTH2026-07-14
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNFW2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNGM2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNGG2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNGL2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNFY2026-07-09
00810174471229Prime Screen®WONDFO USA CO., LTD.NFW2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.NGL2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.NFY2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFW2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NGL2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NGG2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFY2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFV2026-06-26
10722066015053Rapid ResponseBTNX IncPTG2026-05-15
10722066015053Rapid ResponseBTNX IncQAW2026-05-15
10722066015053Rapid ResponseBTNX IncQBF2026-05-15
10722066015053Rapid ResponseBTNX IncPTH2026-05-15
10648564316280SnapCheckDx Rapid Urine THC TestHangzhou Aichek Medical Technology Co., Ltd.NFW2026-05-12
10722066011260Rapid ResponseBTNX IncPTH2026-01-19
10722066011260Rapid ResponseBTNX IncQAW2026-01-19