FDA.reportPublic FDA data

Ecstasy DAU Control, Level 2 Control

Primary DI
B07601680
Brand
Ecstasy DAU Control, Level 2 Control
Company
LIN-ZHI INTERNATIONAL, INC.
Model
0168
Catalog number
0168
Device description
5mL/bottle.Concentration: 625 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
LASDrug Specific Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LASDrug Specific Control MaterialsClinical Toxicology1

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
B07601680PrimaryHIBCC0

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

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Primary DIBrandCompanyProduct codePublished
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B800DAU2SUID0DAU 2 SU IDUTAK LABORATORIES, INC.LAS2026-10-15
B800ISACAL1V2SFUCSF0ISAVUCONAZOLE PLUS CALIBRATOR 1 V2UTAK LABORATORIES, INC.LAS2026-10-07
00812101031254ARK™ Apixaban ControlARK DIAGNOSTICS INCLAS2026-09-25
B800BUP5WBFMSP0BUPRENORPHINE 5NG/MLUTAK LABORATORIES, INC.LAS2026-08-27
B800BUS1DPFEUH0BUSULFAN LEVEL 1UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS2DPFEUH0BUSULFAN LEVEL 2UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS3DPFEUH0BUSULFAN LEVEL 3UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS4DPFEUH0BUSULFAN LEVEL 4UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS5DPFEUH0BUSULFAN LEVEL 5UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS6DPFEUH0BUSULFAN LEVEL 6UTAK LABORATORIES, INC.LAS2026-08-26
B07609770LZI Fentanyl Level 1 ControlLIN-ZHI INTERNATIONAL, INC.LAS2026-07-17
B07609780LZI Fentanyl Level 2 ControlLIN-ZHI INTERNATIONAL, INC.LAS2026-07-17
B800FENTHIGHWBSCFL0FENTANYL PLUS HIGHUTAK LABORATORIES, INC.LAS2026-07-14
B800FENTLOWWBSCFL0FENTANYL PLUS LOWUTAK LABORATORIES, INC.LAS2026-07-14
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B8006TGRQC1UK06TGR PLUS QC LEVEL 1UTAK LABORATORIES, INC.LAS2025-08-06
B8006TGRQC2UK06TGR PLUS QC LEVEL 2UTAK LABORATORIES, INC.LAS2025-08-06
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