FDA.reportPublic FDA data

LZI Tramadol Level 2 Control

Primary DI
B07604180
Brand
LZI Tramadol Level 2 Control
Company
LIN-ZHI INTERNATIONAL, INC.
Model
0418
Catalog number
0418
Device description
5 mL/bottle.Concentration: 125 ng/mL of Tramadol.
Published
2022-05-01
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07604180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tramadol 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 tramadol 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
Premarket exempt
true
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B07609780LZI Fentanyl Level 2 ControlLIN-ZHI INTERNATIONAL, INC.LAS2026-07-17
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