FDA.reportPublic FDA data

Rapid Response

Primary DI
00722066000595
Brand
Rapid Response
Company
BTNX Inc
Model
MOP-1C3-40
Device description
Rapid Response Single Drug Test Cassette (MOP) - 40 tests/ kit are for the qualitative detection of morphine in urine.
Published
2019-10-16
Public version status
Update
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
DNKThin Layer Chromatography, Morphine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DNKThin Layer Chromatography, MorphineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121065000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121065000POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICEPolymed Therapeutics, Inc.2013-05-24DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00722066000595PrimaryGS10
00722066005033Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00722066000595007220660005957220660005950722066000595
00722066005033007220660050337220660050330722066005033

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
40
Kit
true
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
00812203030766Premier BiotechCHEMTRON BIOTECH INCDNK2024-05-28
00812203030773Premier BiotechCHEMTRON BIOTECH INCDNK2024-05-28
00812203030711GenericCHEMTRON BIOTECH INCDNK2024-04-08
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.DNK2024-02-09
06970429841345DTPMCo-Innovation Biotech Co., LtdDNK2023-12-08
06970429841635DTPMCo-Innovation Biotech Co., LtdDNK2023-12-08
16936983144664DiscoverHangzhou AllTest Biotech Co., Ltd.DNK2023-11-30
16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.DNK2023-11-30
00722066006757L-CupBTNX IncDNK2023-04-05
06970429841819co-innovationCo-Innovation Biotech Co., LtdDNK2022-11-11
00812203030575Premier BiotechCHEMTRON BIOTECH INCDNK2022-04-18
00812203030568Premier BiotechCHEMTRON BIOTECH INCDNK2022-04-14
00722066005507Rapid ResponseBTNX IncDNK2022-02-10
00722066005514Rapid ResponseBTNX IncDNK2022-02-10
06970429841444co-innovationCo-Innovation Biotech Co., LtdDNK2022-01-15
06970429841536co-innovationCo-Innovation Biotech Co., LtdDNK2022-01-15
06970429841628co-innovationCo-Innovation Biotech Co., LtdDNK2022-01-15
06970429841703co-innovationCo-Innovation Biotech Co., LtdDNK2022-01-15
06970429841802co-innovationCo-Innovation Biotech Co., LtdDNK2022-01-15
06970429841901co-innovationCo-Innovation Biotech Co., LtdDNK2022-01-15
00041520113405Care One Ahold U.S.A., Inc.DNK2021-08-26
06974464590145DochekGuangzhou Decheng Biotechnology Co., LTDDNK2021-07-30
06974464590152DochekGuangzhou Decheng Biotechnology Co., LTDDNK2021-07-30
00812203030377OSTSCHEMTRON BIOTECH INCDNK2021-06-29
00812203030360Premier BiotechCHEMTRON BIOTECH INCDNK2021-06-25
00096295140576LEADERCardinal Health 110, Inc.DNK2021-06-11
00096295140583LEADERCardinal Health 110, Inc.DNK2021-06-11
50096295140571LEADERCARDINAL HEALTH, INC.DNK2021-06-11
00812203030513ChemtrueCHEMTRON BIOTECH INCDNK2021-06-08
00812203030223GenericCHEMTRON BIOTECH INCDNK2021-05-20