FDA.reportPublic FDA data

Cocaine Metabolite 150 Enzyme Immunoassay

Primary DI
B07603400
Brand
Cocaine Metabolite 150 Enzyme Immunoassay
Company
LIN-ZHI INTERNATIONAL, INC.
Model
0340
Catalog number
0340
Device description
Small Test Kit.Antibody/Substrate Reagent (R1): 100 mL.Enzyme Conjugate Reagent (R2): 37.5 mL.
Published
2016-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113139000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113139000LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLSLin-Zhi International, Inc.2011-11-22DIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07603400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cocaine/cocaine 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 cocaine and/or cocaine metabolites 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

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