FDA.reportPublic FDA data

Rapid Response

Primary DI
10722066008246
Brand
Rapid Response
Company
BTNX Inc
Model
FYL-1CAP156
Device description
Rapid Response Fentanyl Test Cassette
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
DJGEnzyme Immunoassay, Opiates

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233417000AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd.2023-10-26NGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10722066008246PrimaryGS10
00722066008249Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072206600824610722066008246
00722066008249007220660082497220660082490722066008249

GMDN Terms#

Term, Definition table
TermDefinition
Fentanyl 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 fentanyl 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
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
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDJG2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDJG2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDJG2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2019-09-28
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDJG2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2019-02-12
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-07-05
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2018-05-23
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-05-23
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-03-23
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-02-13
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2017-10-12
10694644200444RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2017-06-29
10694644300663RDSAMERICAN BIO MEDICA CORPORATIONDJG2017-06-08
10694644300670RDSAMERICAN BIO MEDICA CORPORATIONDJG2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2017-06-08
10694644300649RDSAMERICAN BIO MEDICA CORPORATIONDJG2017-04-06