FDA.reportPublic FDA data

Rapid Response

Primary DI
00722066007549
Brand
Rapid Response
Company
BTNX Inc
Model
D12.5-1VF
Device description
12 Panel One Step DOA Cup (12.5) - AMP1000 BAR300 BUP10 BZO300 COC300 MDMA500 MTD300 MET1000 OPI2000 OXY100 THC50 PCP25
Published
2023-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFYTest, Cocaine And Cocaine Metabolites, 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
10722066007546PrimaryGS10
00722066007549Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072206600754610722066007546
00722066007549007220660075497220660075490722066007549

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
251005005
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10722066005511Rapid ResponseD6.6.3-1V2026-10-09
10722066018979Rapid ResponseD10.3-1VF2026-10-08
10722066019013Rapid ResponseD10.32-1VF2026-10-08
10722066019020Rapid ResponseD5.75-1VF2026-10-08
10722066019037Rapid ResponseD13.5-1VF2026-10-08
10722066019044Rapid ResponseD12.49-1VAF2026-10-08
10722066018955Rapid ResponseD5.1-1VF2026-10-06
10722066018696Rapid ResponseD7.3-1VF2026-09-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00311917077932WalgreensWALGREEN CO.NFY2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFY2026-10-13
10722066005511Rapid ResponseBTNX IncNFY2026-10-09
10722066018979Rapid ResponseBTNX IncNFY2026-10-08
10722066019013Rapid ResponseBTNX IncNFY2026-10-08
10722066019020Rapid ResponseBTNX IncNFY2026-10-08
10722066019037Rapid ResponseBTNX IncNFY2026-10-08
10722066019044Rapid ResponseBTNX IncNFY2026-10-08
10722066018955Rapid ResponseBTNX IncNFY2026-10-06
10722066018696Rapid ResponseBTNX IncNFY2026-09-18
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNFY2026-08-14
06936983114066Alltest COC150 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-21
06936983114318Alltest COC150 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFY2026-04-21
06936983114394Alltest COC150 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFY2026-04-21
06936983114554Alltest COC150 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-21
06936983114707Alltest COC150 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-21
06936983113915Alltest COC150 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-17
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
06936983114790Alltest Multi-Drug 15 Drugs Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
06936983114806Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
06936983114813Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
06936983114820Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16
06936983114837Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFY2026-04-16