FDA.reportPublic FDA data

Ecstasy DAU Calibrator, High Calibrator

Primary DI
B07601650
Brand
Ecstasy DAU Calibrator, High Calibrator
Company
LIN-ZHI INTERNATIONAL, INC.
Model
0165
Catalog number
0165
Device description
5mL/bottle.Concentration: 1000 ng/mL of MDMA.
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
K033094000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033094000ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)Lin-Zhi International, Inc.2003-12-19DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07601650PrimaryHIBCC0

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
B07609700LZI Fentanyl III Enzyme Immunoassay097009702026-07-17
B07609710LZI Fentanyl III Enzyme Immunoassay097109712026-07-17
B07609730LZI Fentanyl Cutoff Calibrator097309732026-07-17
B07609770LZI Fentanyl Level 1 Control097709772026-07-17
B07609780LZI Fentanyl Level 2 Control097809782026-07-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00812101031650ARK™ Ketamine II Calibrator (100 ng/mL Cutoff)ARK DIAGNOSTICS INCDLJ2025-12-27
00850624008650LZI Fentanyl Qualitative CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2025-10-13
00840937114568ImmunalysisIMMUNALYSIS CORPDLJ2024-04-08
00840937114605ImmunalysisIMMUNALYSIS CORPDLJ2024-04-08
07613336224830MTX CalibratorRoche Diagnostics GmbHDLJ2024-03-25
00840937103265ImmunalysisIMMUNALYSIS CORPDLJ2023-10-26
00840937103272ImmunalysisIMMUNALYSIS CORPDLJ2023-10-26
00840937103289ImmunalysisIMMUNALYSIS CORPDLJ2023-10-26
00840937103296ImmunalysisIMMUNALYSIS CORPDLJ2023-10-26
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B07604130LZI Tramadol Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07604140LZI Tramadol Intermediate CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07604150LZI Tramadol High CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07605220LZI Cotinine II Low CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
B07605230LZI Cotinine II Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
B07605240LZI Cotinine II Intermediate CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
B07605250LZI Cotinine II High CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
00894354002212MyCare PsychiatrySALADAX BIOMEDICAL, INC.DLJ2022-01-27
00850624008278Fentanyl Qualitative Calibrator SetLIN-ZHI INTERNATIONAL, INC.DLJ2021-10-18
00812101030509ARK™ HS Benzodiazepine II CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
00812101030516ARK™ HS Benzodiazepine II Negative CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
00812101030523ARK™ HS Benzodiazepine II 100ng/mL Cutoff CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
00812101030530ARK™ HS Benzodiazepine II 200ng/mL Cutoff CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
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