FDA.reportPublic FDA data

Rapid Response

Primary DI
00722066004951
Brand
Rapid Response
Company
BTNX Inc
Model
MTD-1S3-100
Device description
Single Drug Test Strip - 100/kit Methadone (MTD) - Cut-off 300 ng/ml
Published
2019-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DJCThin Layer Chromatography, Methamphetamine
LDJEnzyme Immunoassay, Cannabinoids
NGLTest, Opiates, Over The Counter
PTGTest, Methadone, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2
PTGTest, Methadone, Over The CounterClinical 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
00722066004951PrimaryGS10
00722066004944Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00722066004951007220660049517220660049510722066004951
00722066004944007220660049447220660049440722066004944

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
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10722066018696Rapid ResponseD7.3-1VF2026-09-18
10722066018009Rapid ResponseD13.5-1VA2026-07-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LDJ2026-09-24
10722066018696Rapid ResponseBTNX IncPTG2026-09-18
10722066018696Rapid ResponseBTNX IncNGL2026-09-18
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-08-14
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyLDJ2026-07-31
00840050500170OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11