FDA.reportPublic FDA data

Salimetrics

Primary DI
00859410006092
Brand
Salimetrics
Company
SALIMETRICS, LLC
Model
N/A
Catalog number
1-2112-5
Device description
High Sensitivity Salivary Cotinine Quantitative Enzyme Immunoassay Kit (5-pack)
Published
2018-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MKUEnzyme Immunoassasy, Nocotine And Nicotine Metabolites
MRSTest System, Nicotine, Cotinine, Metabolites

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859410006092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859410006092008594100060928594100060920859410006092

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

Regulatory Flags#

DUNS number
084843064
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
00859410006351SalimetricsN/A5016.042025-12-10
00859410006368SalimetricsN/A5016.04B2025-12-10
00859410006375SalimetricsN/A5001.022025-12-10
00859410006344SalivaBioN/A5001.06B2025-11-24
00859410006283SalimetricsN/A5004.012024-12-27
00859410006290SalimetricsN/A5004.042024-12-27
00859410006306SalimetricsN/A5004.022024-12-27
00859410006313SalimetricsN/A5004.032024-12-27
00859410006320SalimetricsN/A5004.062024-12-27
00859410006337SalimetricsN/A5004.052024-12-27
00859410006269SalimetricsN/A1-44102024-09-18
00859410006276SalimetricsN/A1-4410-52024-09-18
00859410006245SalimetricsN/A1-3512-52023-09-26
00859410006252SalimetricsN/A1-35122023-09-26
00859410006139SalimetricsN/A1-23122022-08-23
00859410006177SalimetricsN/A1-2312-52022-08-23
00859410006009SalivaBioN/A5016.042022-10-13
00859410006214SalivaBioN/A5016.04B2022-10-13
00859410006221SalivaBioN/A5016.062022-10-13
00859410006238SalivaBioN/A5016.06B2022-10-13

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
10722066008376Rapid ResponseBTNX IncMKU2024-08-14
00722066008379Rapid ResponseBTNX IncMKU2024-08-14
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
10722066008369Rapid ResponseBTNX IncMKU2024-02-26
00810124273309SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200)Alere San Diego, Inc.MKU2023-12-15
10810124273306SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200)ALERE SAN DIEGO, INC.MKU2023-12-15
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