FDA.reportPublic FDA data

Kit, MP Cotinine Serum 100 plate

Primary DI
00608337000030
Brand
Kit, MP Cotinine Serum 100 plate
Company
Orasure Technologies, Inc.
Model
1124EC
Published
2021-01-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00608337000030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00608337000030006083370000306083370000300608337000030

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
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6108821820customercare@orasure.com

Regulatory Flags#

DUNS number
114152184
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00608337000115OraSure Oral Fluid Collection Device3001-28702019-02-15
00608337000559Histofreezer1001-03752016-09-15
00608337360103Histofreezer1001-02952016-09-15
00608337365108Histofreezer1001-02942016-09-15
00608337402100Histofreezer1001-02932016-09-15
20608337000065OraSure Quick Flu 22-Count Flu A + B Kit1001-03202016-11-10
00608337000047OraSure Quickflu Nasopharyngeal Wash / Aspirate1001-03212016-11-25
00608337000054OraSure QuickFlu Positive and Negative Control Kit1001-03232018-03-23
00608337001297Histofreezer1001-03362016-09-16
10608337001850OraQuick HIV Self-Test3001-3822U22026-05-08
00608337001860OraQuick HIV Self-Test3001-3822UR22026-05-08
00608337000078Intercept3001-28692016-07-29
00608337150308Q.E.D. Saliva Alcohol Test A150601562016-07-29
00608337000023Methamphetamine Intercept 2 Plate Kit1104IT2016-09-12
00608337000085Auto-Lyte1224UM1224UM2016-04-29
00608337000146Amphetamine Intercept 5 Plate Kit1103IB2016-09-12
00608337000153Amphetamine Intercept 100 Plate Kit1103IC2016-09-12
00608337000184Methamphetamine Intercept 5 Plate Kit1104IB2016-09-12
00608337000191Methamphetamine Intercept 100 Plate Kit1104IC2016-09-12
00608337000207Barbiturates Intercept 5 Plate Kit1108IB2016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10722066008376Rapid ResponseBTNX IncMKU2024-08-14
00722066008379Rapid ResponseBTNX IncMKU2024-08-14
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
B07605200LZI Cotinine II Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.MKU2022-04-22
B07605210LZI Cotinine II Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.MKU2022-04-22
00859410006092SalimetricsSALIMETRICS, LLCMKU2018-09-14
00859410006108SalimetricsSALIMETRICS, LLCMKU2018-09-14
00884883001077DRI Cotinine Low ControlMicrogenics CorporationMKU2017-10-18
00884883001084DRI Cotinine High ControlMicrogenics CorporationMKU2017-10-18
00895160002366Nano-CheckTM Nicotine 500NANO-DITECH CORPORATIONMKU2016-10-04
00884883002876DRI Cotinine AssayMicrogenics CorporationMKU2016-09-24
10743816000235AccuSign® Nicotine cardPRINCETON BIOMEDITECH CORPORATIONMKU2016-09-23
10743816000242Status™ Nicotine cardPRINCETON BIOMEDITECH CORPORATIONMKU2016-09-23
00884883001053DRI Cotinine AssayMicrogenics CorporationMKU2016-09-22
00884883001060DRI Cotinine Calibrator KitMicrogenics CorporationMKU2016-09-22
00608337000399Cotinine Serum 5 Plate KitOrasure Technologies, Inc.MKU2016-09-16
00608337000405Cotinine Serum 2 Plate KitOrasure Technologies, Inc.MKU2016-09-16
00608337000665Cotinine OraSure 5 Plate KitOrasure Technologies, Inc.MKU2016-09-16
00608337000672Cotinine OraSure 100 Plate KitOrasure Technologies, Inc.MKU2016-09-16
00895160002359Nano-CheckTM NicotineNANO-DITECH CORPORATIONMKU2016-09-12
00884883012905DRI Cotinine AssayMicrogenics CorporationMKU2016-09-12
00608337000085Auto-LyteOrasure Technologies, Inc.MKU2016-04-29
00608337000474Auto-LyteOrasure Technologies, Inc.MKU2016-04-29