FDA.reportPublic FDA data

Rapid Response

Primary DI
10722066007553
Brand
Rapid Response
Company
BTNX Inc
Model
D10.3-1VF
Device description
10 Panel One Step DOA Cup(10.3) - COC300 AMP1000 MET1000 THC50 OPI2000 PCP25 BAR300 BZO300 MTD300 MDMA500
Published
2023-08-04
Public version status
New
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

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

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
10722066007553PrimaryGS10
00722066007556Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072206600755310722066007553
00722066007556007220660075567220660075560722066007556

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
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
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
10722066015053Rapid ResponseBTNX IncPTG2026-05-15
10722066015053Rapid ResponseBTNX IncNGL2026-05-15
10722066015053Rapid ResponseBTNX IncNGM2026-05-15
10722066015053Rapid ResponseBTNX IncNGG2026-05-15
10722066015053Rapid ResponseBTNX IncNFY2026-05-15
10722066015053Rapid ResponseBTNX IncNFW2026-05-15
10722066015053Rapid ResponseBTNX IncPTH2026-05-15
10722066015053Rapid ResponseBTNX IncNFV2026-05-15
10722066015084Rapid ResponseBTNX IncPTH2026-05-15
10722066015084Rapid ResponseBTNX IncPTG2026-05-15
10722066015084Rapid ResponseBTNX IncNFY2026-05-15
10722066015084Rapid ResponseBTNX IncNGL2026-05-15
10722066015084Rapid ResponseBTNX IncNGM2026-05-15
10722066015084Rapid ResponseBTNX IncNGG2026-05-15
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 IncNGL2026-01-19
10722066011260Rapid ResponseBTNX IncNFV2026-01-19
10722066011260Rapid ResponseBTNX IncNGG2026-01-19
10722066011260Rapid ResponseBTNX IncPTH2026-01-19
10722066011260Rapid ResponseBTNX IncPTG2026-01-19
10722066011260Rapid ResponseBTNX IncNFY2026-01-19
10722066011260Rapid ResponseBTNX IncNFW2026-01-19
10722066011277Rapid ResponseBTNX IncNFW2026-01-19
10722066011277Rapid ResponseBTNX IncNGM2026-01-19
10722066011277Rapid ResponseBTNX IncNFY2026-01-19
10722066011277Rapid ResponseBTNX IncNGG2026-01-19
10722066011277Rapid ResponseBTNX IncPTH2026-01-19