Multi-Analyte DAU Calibrator Set D, High Calibrator 0875

GUDID B07608750

15 mL/bottle. Concentration of Multi-Analyte: 3000 ng/mL benzoylecgonine, 2000 ng/mL d-methamphetamine, 1000 ng/mL morphine, 1000 ng/mL oxazepam, and 500 ng/mL oxycodone.

LIN-ZHI INTERNATIONAL, INC.

Multiple drugs of abuse IVD, calibrator
Primary Device IDB07608750
NIH Device Record Key3f855635-8b1c-495c-ba16-75eb89ea7f91
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti-Analyte DAU Calibrator Set D, High Calibrator
Version Model Number0875
Catalog Number0875
Company DUNS840839190
Company NameLIN-ZHI INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB07608750 [Primary]

FDA Product Code

DKBCalibrators, Drug Mixture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-03
Device Publish Date2019-03-26

Devices Manufactured by LIN-ZHI INTERNATIONAL, INC.

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