FDA.reportPublic FDA data

Methadone Metabolite DAU Control, Level 2 Control

Primary DI
B07601980
Brand
Methadone Metabolite DAU Control, Level 2 Control
Company
LIN-ZHI INTERNATIONAL, INC.
Model
0198
Catalog number
0198
Device description
5mL/bottle.Concentration: 375 ng/mL of EDDP.
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
DJREnzyme Immunoassay, Methadone
DLJCalibrators, Drug Specific

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DLJCalibrators, Drug SpecificClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031797000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031797000METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)Lin-Zhi International, Inc.2003-10-10DJR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07601980PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of the methadone metabolite 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in a clinical specimen.

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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B07601600Ecstasy Enzyme Immunoassay016001602016-07-05
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