FDA.reportPublic FDA data

Rapid Response

Primary DI
00722066008379
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
Rx
false
OTC
true
Sterile
false
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.

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
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
10722066008376Rapid 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