FDA.reportPublic FDA data

Rapid Response

Primary DI
00722066008058
Brand
Rapid Response
Company
BTNX Inc
Model
D10.1-1V
Device description
One Step DOA Cup MOR 2000 (Urine) (D10.1)- COC300 AMP1000 MET1000 THC50 MTD300 OPI2000 PCP25 BAR300 BZO300 TCA1000
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
NGITest, Morphine, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGITest, Morphine, 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
10722066008055PrimaryGS10
00722066008058Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072206600805510722066008055
00722066008058007220660080587220660080580722066008058

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
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
16942598226046Identify Diagnostics Multi-Drug Test Cup Hangzhou AllTest Biotech Co., Ltd.NGI2026-04-08
16942598201654DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201661DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201678DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201685DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201692DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201708DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201715DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201739DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201746DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201753DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201760DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201777DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201784DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201807DrugTect Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201814DrugTect Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201821DrugTect Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201838DrugTect Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201845DrugTect Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201852DrugTect Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201647DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
06942598201671DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
06942598201688DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201722DrugTect Multi-Drug Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
16942598201791DrugTect Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.NGI2025-11-15
06977469280189U-Catch XR Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.NGI2024-12-18
06977469280004U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.NGI2024-12-17
06977469280011U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.NGI2024-12-17
06977469280042U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.NGI2024-12-17
10722066008055Rapid ResponseBTNX IncNGI2024-04-01