FDA.reportPublic FDA data

Amphetamines DAU Calibrator, Cutoff Calibrator

Primary DI
B07600430
Brand
Amphetamines DAU Calibrator, Cutoff Calibrator
Company
LIN-ZHI INTERNATIONAL, INC.
Model
0043
Catalog number
0043
Device description
5mL/bottle.Concentration: 1000 ng/mL of Methamphetamine.
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
DLJCalibrators, Drug Specific

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLJCalibrators, Drug SpecificClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020769000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020769000SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLSLin-Zhi International, Inc.2002-04-03DLJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07600430PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Methamphetamine-specific IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of a specific methamphetamine 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

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

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