FDA.reportPublic FDA data

Rapid Response

Primary DI
00722066007952
Brand
Rapid Response
Company
BTNX Inc
Model
D5.75-1VF
Device description
One Step 5 Panel DOA Cup (5.75) - COC300 MET1000 AMP1000 OPI2000 OXY100
Published
2024-04-01
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
NFTTest, Amphetamine, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180349000AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd.2018-04-05NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10722066007959PrimaryGS10
00722066007952Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072206600795910722066007959
00722066007952007220660079527220660079520722066007952

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
251005005
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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
00722066009604Rapid ResponseCOF-19CGHU22025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500293OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500309OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500316OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500323OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500330OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500347OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500354OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500361OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500378OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500385OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500392OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500408OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500415OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500422OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500439OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500446OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500453OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500460OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11