FDA.reportPublic FDA data

Rapid Response

Primary DI
10722066005108
Brand
Rapid Response
Company
BTNX Inc
Model
D4.43-1P29-25
Device description
Multi Drug Test Panel (4.43) - BZO300 MET1000 BUP10 OPI2000
Published
2020-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
JXMEnzyme Immunoassay, Benzodiazepine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161044000AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)Assure Tech. (Hangzhou) Co, Ltd.2016-07-06DJC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10722066005108PrimaryGS10
00722066005101Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072206600510810722066005108
00722066005101007220660051017220660051010722066005101

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.

Regulatory Flags#

DUNS number
251005005
Device count
25
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
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJC2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2020-05-29
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2019-02-12
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2019-02-12
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2019-02-12
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2018-03-30
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.JXM2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2017-06-08
10694644200017RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644200017RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXM2016-09-23
10694644200024RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644200024RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXM2016-09-23
10694644200031RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644200031RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXM2016-09-23
10694644200048RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXM2016-09-23
10694644200048RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644200055RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2016-09-23