FDA.reportPublic FDA data

Rapid Response

Primary DI
10722066008376
Brand
Rapid Response
Company
BTNX Inc
Model
COT-2FC141
Device description
Rapid Response Saliva Drug Test (COT)
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
MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKUEnzyme Immunoassay, Nicotine And Nicotine MetabolitesClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223162000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223162000Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTHealgen Scientific,, LLC2023-03-17LDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10722066008376PrimaryGS10
00722066008379Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072206600837610722066008376
00722066008379007220660083797220660083790722066008379

GMDN Terms#

Term, Definition table
TermDefinition
Cotinine 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 cotinine (nicotine metabolite) 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 to aid in the differentiation of smokers and non-smokers, or in the investigation of the link between smoking and associated disorders (e.g., cancer, coronary heart disease, stroke). 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
00722066008379Rapid ResponseBTNX IncMKU2024-08-14
10722066008369Rapid ResponseBTNX IncMKU2024-02-26
00810124273309SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200)Alere San Diego, Inc.MKU2023-12-15
10810124273306SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200)ALERE SAN DIEGO, INC.MKU2023-12-15
B07605200LZI Cotinine II Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.MKU2022-04-22
B07605210LZI Cotinine II Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.MKU2022-04-22
00608337000030Kit, MP Cotinine Serum 100 plateOrasure Technologies, Inc.MKU2021-01-22
00859410006092SalimetricsSALIMETRICS, LLCMKU2018-09-14
00859410006108SalimetricsSALIMETRICS, LLCMKU2018-09-14
00884883001077DRI Cotinine Low ControlMicrogenics CorporationMKU2017-10-18
00884883001084DRI Cotinine High ControlMicrogenics CorporationMKU2017-10-18
00895160002366Nano-CheckTM Nicotine 500NANO-DITECH CORPORATIONMKU2016-10-04
00884883002876DRI Cotinine AssayMicrogenics CorporationMKU2016-09-24
10743816000235AccuSign® Nicotine cardPRINCETON BIOMEDITECH CORPORATIONMKU2016-09-23
10743816000242Status™ Nicotine cardPRINCETON BIOMEDITECH CORPORATIONMKU2016-09-23
00884883001053DRI Cotinine AssayMicrogenics CorporationMKU2016-09-22
00884883001060DRI Cotinine Calibrator KitMicrogenics CorporationMKU2016-09-22
00608337000399Cotinine Serum 5 Plate KitOrasure Technologies, Inc.MKU2016-09-16
00608337000405Cotinine Serum 2 Plate KitOrasure Technologies, Inc.MKU2016-09-16
00608337000665Cotinine OraSure 5 Plate KitOrasure Technologies, Inc.MKU2016-09-16
00608337000672Cotinine OraSure 100 Plate KitOrasure Technologies, Inc.MKU2016-09-16
00895160002359Nano-CheckTM NicotineNANO-DITECH CORPORATIONMKU2016-09-12
00884883012905DRI Cotinine AssayMicrogenics CorporationMKU2016-09-12
00608337000085Auto-LyteOrasure Technologies, Inc.MKU2016-04-29
00608337000474Auto-LyteOrasure Technologies, Inc.MKU2016-04-29