FDA.reportPublic FDA data

Rapid Response

Primary DI
10722066008611
Brand
Rapid Response
Company
BTNX Inc
Model
D4.59-1VF
Device description
D4.59-1VF- AMP1000 COC300 MOP2000 PCP25
Published
2024-08-14
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
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGLTest, Opiates, Over The Counter
NGMTest, Phencyclidine (Pcp), Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2
NGMTest, Phencyclidine (Pcp), Over The CounterUnknownU

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
10722066008611PrimaryGS10
00722066008614Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072206600861110722066008611
00722066008614007220660086147220660086140722066008614

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
10722066018009Rapid ResponseD13.5-1VA2026-07-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNFY2026-08-14
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNFT2026-08-14
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-08-14
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFY2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NGM2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFY2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NGM2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NGM2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFY2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NFY2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NGM2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NFY2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NGM2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NFY2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NGM2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NFY2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NGM2022-11-11