FDA.reportPublic FDA data

Rapid Response

Primary DI
00722066004548
Brand
Rapid Response
Company
BTNX Inc
Model
D12.5-1V
Published
2019-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NFTTest, Amphetamine, Over The Counter
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
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180349000AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd.2018-04-05NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10722066004545PackageGS125In Commercial Distribution
17220660045481PackageGS16In Commercial Distribution
00722066004548PrimaryGS10
00722066004555Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072206600454510722066004545
1722066004548117220660045481
00722066004548007220660045487220660045480722066004548
00722066004555007220660045557220660045550722066004555

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10722066015053Rapid ResponseD12.49-1VAF2026-05-15
10722066015084Rapid ResponseD13.5-1VF2026-05-15
10722066011260Rapid ResponseD13.5-1VF2026-01-19
10722066011277Rapid ResponseD12.49-1VAF2026-01-19
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
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
00722066010754Rapid ResponseSTR-15SGPU-252025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10648564316280SnapCheckDx Rapid Urine THC TestHangzhou Aichek Medical Technology Co., Ltd.NFW2026-05-12
10197344170203MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-29
10197344170210MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-23
10722066011260Rapid ResponseBTNX IncNGM2026-01-19
10722066011260Rapid ResponseBTNX IncNFW2026-01-19
10722066011260Rapid ResponseBTNX IncNFV2026-01-19
10722066011260Rapid ResponseBTNX IncNGL2026-01-19
10722066011260Rapid ResponseBTNX IncPTG2026-01-19
10722066011260Rapid ResponseBTNX IncNGG2026-01-19
10722066011260Rapid ResponseBTNX IncNFY2026-01-19
10722066011260Rapid ResponseBTNX IncQBF2026-01-19
10722066011260Rapid ResponseBTNX IncPTH2026-01-19
10722066011260Rapid ResponseBTNX IncQAW2026-01-19
10722066009083Rapid ResponseBTNX IncPTG2025-10-03
10722066009083Rapid ResponseBTNX IncNGG2025-10-03
10722066009083Rapid ResponseBTNX IncNFW2025-10-03
10722066009083Rapid ResponseBTNX IncNGL2025-10-03
10722066009083Rapid ResponseBTNX IncPTH2025-10-03
10722066009083Rapid ResponseBTNX IncNGM2025-10-03
10722066009083Rapid ResponseBTNX IncQAW2025-10-03
10722066009083Rapid ResponseBTNX IncNFY2025-10-03
10722066009083Rapid ResponseBTNX IncNFV2025-10-03
10722066010973Rapid ResponseBTNX IncNGG2025-07-08
10722066010973Rapid ResponseBTNX IncNFY2025-07-08
10722066010973Rapid ResponseBTNX IncPTH2025-07-08
10722066010973Rapid ResponseBTNX IncNGL2025-07-08
10722066010973Rapid ResponseBTNX IncPTG2025-07-08
10722066010973Rapid ResponseBTNX IncNGM2025-07-08
10722066010973Rapid ResponseBTNX IncNFW2025-07-08
10722066010973Rapid ResponseBTNX IncNFV2025-07-08