FDA.reportPublic FDA data

Cotinine ELISA

Primary DI
00840239059178
Brand
Cotinine ELISA
Company
DRG International Inc
Model
EIA-5917
Catalog number
EIA-5917
Device description
The Cotinine ELISA Kit is intended for the measurement of Cotinine in serum, urine.
Published
2019-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239059178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239059178008402390591788402390591780840239059178

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

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