FDA.reportPublic FDA data

SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200)

Primary DI
10810124273306
Brand
SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200)
Company
ALERE SAN DIEGO, INC.
Model
DCT-102a
Published
2023-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
00810124273309PrimaryGS10
10810124273306Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810124273309008101242733098101242733090810124273309
1081012427330610810124273306

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
194854949
Device count
40
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00810124272975CERTUM One Step Multi-Line Drug Screen EZ SplitDBO-167-022-a45651613262024-10-10
00810124272982SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 300)DAM-A101-a-Sgl2023-12-15
00810124272999SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 1000)DAM-101-a-Sgl2023-12-15
00810124273002SureStepTM Urine Test Drug Screen Strip, Barbiturates (BAR 300)DBA-101-a-Sgl2023-12-15
00810124273019SureStepTM Urine Test Drug Screen Strip, Buprenorphine (BUP10)DBU-101-a-Sgl2023-12-15
00810124273026SureStepTM Urine Test Drug Screen Strip, Benzodiazepines (BZO 300)DBZ-101-a-Sgl2023-12-15
00810124273033SureStepTM Urine Test Drug Screen Strip, Cocaine (COC 150)DCO-U101-a-Sgl2023-12-15
00810124273040SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 500)DME-U101-a-Sgl2023-12-15
00810124273057SureStepTM Urine Test Drug Screen Strip, Methylenedioxymethamphetamine (MDMA 500DMD-101-a-Sgl2023-12-15
00810124273064SureStepTM Urine Test Drug Screen Strip, Opiate (MOP 300)DMO-101-a-Sgl2023-12-15
00810124273071SureStepTM Urine Test Drug Screen Strip, Methadone (MTD 300)DMT-101-a-Sgl2023-12-15
00810124273088SureStepTM Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000)DTC-101-a-Sgl2023-12-15
00810124273095SureStepTM Urine Test Drug Screen Strip, Marijuana (THC 50)DTH-101-a-Sgl2023-12-15
00810124273149SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-157-01245653390192024-09-17
00810124273156SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-167-52145653490192024-09-17
00810124273163SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-1107-02145653590192024-09-17
00810124273170SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-1107-01145653690192024-09-17
00810124273200SureStepTM Urine Test Drug Screen Strip, Cocaine (COC 300)DCO-101-a-Sgl2023-12-15
00810124273217SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 1000)DME-101-a-Sgl2023-12-15
00810124273224SureStepTM Urine Test Drug Screen Strip, Opiate (OPI 2000)DMO-101-a-Sgl2023-12-15

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
B07605200LZI Cotinine II Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.MKU2022-04-22
B07605210LZI Cotinine II Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.MKU2022-04-22
00608337000030Kit, MP Cotinine Serum 100 plateOrasure Technologies, Inc.MKU2021-01-22
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