FDA.reportPublic FDA data

Accutest NicAlert Urine Cotinine Test

Primary DI
10763924047182
Brand
Accutest NicAlert Urine Cotinine Test
Company
JANT PHARMACAL CORPORATION
Model
DS47NY150
Device description
Semi quantitative test for the detection of Cotinine (Nicotine Metabolite) in a Urine specimen
Published
2016-09-24
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
MRSTest System, Nicotine, Cotinine, Metabolites

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRSTest System, Nicotine, Cotinine, MetabolitesClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021688000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021688000NICALERTNymox Pharmaceutical Corporation2002-10-18MRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10763924047182PrimaryGS10
00763924047185Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076392404718210763924047182
00763924047185007639240471857639240471850763924047185

GMDN Terms#

Term, Definition table
TermDefinition
Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cotinine (nicotine metabolite) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Regulatory Flags#

DUNS number
797393659
Device count
50
Lot or batch
true
Expiration date on label
true

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10763924850508Accustrip Urine Reagent Strip ReaderUA8502016-09-24
10763924870100Accustrip 10-Parameter Urine Reagent Strip UA870007639248701032016-09-24
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936983197090iScreenTM Oral Fluid Drug TestHangzhou AllTest Biotech Co., Ltd.MRS2025-09-26
06974246462349FIRSTVIEW COT Urine Dip Card TestSafecare Biotech (Hangzhou) Co., Ltd.MRS2025-07-07
06970429843417co-innovationCo-Innovation Biotech Co., LtdMRS2025-05-19
16970429843414co-innovationCo-Innovation Biotech Co., LtdMRS2025-05-19
06936983177252FirstCheck Cotinine Oral Fluid TestHangzhou AllTest Biotech Co., Ltd.MRS2025-02-14
00816862026191Prime ScreenWONDFO USA CO., LTD.MRS2024-12-24
10816862026198Prime ScreenWONDFO USA CO., LTD.MRS2024-12-24
06977469280097U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold)Eterbio, Inc.MRS2024-12-18
06977469280158U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) Eterbio, Inc.MRS2024-12-18
00850065976280UScreen OralGuangzhou Decheng Biotechnology Co., LTDMRS2024-09-27
00850065976297UScreen OralGuangzhou Decheng Biotechnology Co., LTDMRS2024-09-27
00850065976303UScreen OralGuangzhou Decheng Biotechnology Co., LTDMRS2024-09-27
00850054867025AmazewellGuangzhou Decheng Biotechnology Co., LTDMRS2024-09-26
30850054867026AmazewellGuangzhou Decheng Biotechnology Co., LTDMRS2024-09-26
00810038636443Easy@Home Nicotine Urine Test (5 tests one kit)EASY HEALTHCARE CORPORATIONMRS2024-07-17
20810038636447Easy@Home Nicotine Urine Test (5 tests one kit)EASY HEALTHCARE CORPORATIONMRS2024-07-17
06974246461465T Testahead Cotinine(COT) Urine Test DipcardSafecare Biotech (Hangzhou) Co., Ltd.MRS2024-06-27
06974246461472T Testahead Cotinine(COT) Urine Test DipcardSafecare Biotech (Hangzhou) Co., Ltd.MRS2024-06-27
06974246461489T Testahead Cotinine(COT) Urine Test DipcardSafecare Biotech (Hangzhou) Co., Ltd.MRS2024-06-27
06974246460987EXPLORO Highly Sensitive NICOTINE URINE TESTSafecare Biotech (Hangzhou) Co., Ltd.MRS2023-12-01
06974246460994EXPLORO Highly Sensitive NICOTINE URINE TESTSafecare Biotech (Hangzhou) Co., Ltd.MRS2023-12-01
06974246461007EXPLORO Highly Sensitive NICOTINE URINE TESTSafecare Biotech (Hangzhou) Co., Ltd.MRS2023-12-01
06974246461014EXPLORO Highly Sensitive NICOTINE URINE TESTSafecare Biotech (Hangzhou) Co., Ltd.MRS2023-12-01
06974246460840FIRSTVIEW COT Urine Dip card TestSafecare Biotech (Hangzhou) Co., Ltd.MRS2023-09-05
04048474059175Cotinine ELISADRG Instruments Gesellschaft mit beschränkter HaftungMRS2023-09-01
00810038634654Areta Cotinine Test Strip -COT(10 tests one kit)EASY HEALTHCARE CORPORATIONMRS2023-07-19
00810038634661Areta Cotinine Test Strip(25tests one kit)EASY HEALTHCARE CORPORATIONMRS2023-07-19
30810038634655Areta Cotinine Test Strip -COT(10 tests one kit)EASY HEALTHCARE CORPORATIONMRS2023-07-19
30810038634662Areta Cotinine Test Strip(25tests one kit)EASY HEALTHCARE CORPORATIONMRS2023-07-19
06972428162186U-CatchShenzhen Bioeasy Biotechnology Co., LtdMRS2023-03-09