FDA.reportPublic FDA data

LZI Cotinine II Enzyme Immunoassay

Primary DI
B07605200
Brand
LZI Cotinine II Enzyme Immunoassay
Company
LIN-ZHI INTERNATIONAL, INC.
Model
0520
Catalog number
0520
Device description
Small Test Kit.Antibody/Substrate Reagent (R1): 100 mL.Enzyme Conjugate Reagent (R2): 37.5 mL.
Published
2022-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192299000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192299000LZI Cotinine II Enzyme ImmunoassayLin-Zhi International, Inc.2019-11-21MKU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07605200PrimaryHIBCC0

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
840839190
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
00850624008643Fentanyl II Enzyme Immunoassay10427531190104275311902025-11-17
00850624008544LZI Fentanyl III Enzyme ImmunoassayC82916C829162025-10-13
00850624008650LZI Fentanyl Qualitative CalibratorD26784D267842025-10-13
00850624008667LZI Fentanyl Level 1 ControlD26785D267852025-10-13
00850624008674LZI Fentanyl Level 2 ControlD26786D267862025-10-13
00850624008681LZI Fentanyl III Enzyme ImmunoassayD29739D297392025-10-13
00850624008636Fentanyl Control Set10426667190104266671902025-06-06
B07600400Amphetamines Enzyme Immunoassay004000402016-07-05
B07600410Amphetamines Enzyme Immunoassay004100412016-07-05
B07601000Amphetamines 500 Enzyme Immunoassay010001002016-07-05
B07601010Amphetamines 500 Enzyme Immunoassay010101012016-07-05
B07601600Ecstasy Enzyme Immunoassay016001602016-07-05
B07601610Ecstasy Enzyme Immunoassay016101612016-07-05
B07601620Ecstasy DAU Calibrator, Low Calibrator016201622016-07-05
B07601630Ecstasy DAU Calibrator, Cutoff Calibrator016301632016-07-05
B07601640Ecstasy DAU Calibrator, Intermediate Calibrator016401642016-07-05
B07601650Ecstasy DAU Calibrator, High Calibrator016501652016-07-05
B07601670Ecstasy DAU Control, Level 1 Control016701672016-07-05
B07601680Ecstasy DAU Control, Level 2 Control016801682016-07-05
B0760002C0Cannabinoids DAU Calibrator, Negative Calibrator0002c0002c2016-07-05

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
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