Carisprodol Metabolite (Meprobamate) DAU Calibrator, High Calibrator 0375

GUDID B07603750

5mL/bottle. Concentration: 400 ng/mL of Meprobamate.

LIN-ZHI INTERNATIONAL, INC.

Carisoprodol IVD, calibrator Carisoprodol IVD, calibrator
Primary Device IDB07603750
NIH Device Record Key97d1b7a8-83d3-43d0-b77c-4377e2866373
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarisprodol Metabolite (Meprobamate) DAU Calibrator, High Calibrator
Version Model Number0375
Catalog Number0375
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB07603750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DLJCalibrators, Drug Specific
QBKMeprobamate Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-03
Device Publish Date2018-09-18

Devices Manufactured by LIN-ZHI INTERNATIONAL, INC.

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