Hydrocodone 100 DAU Calibrator, High Calibrator 0385

GUDID B07603850

5mL/bottle. Concentration: 300 ng/mL of Hydrocodone.

LIN-ZHI INTERNATIONAL, INC.

Opiate/opiate metabolite IVD, calibrator Opiate/opiate metabolite IVD, calibrator
Primary Device IDB07603850
NIH Device Record Key47351b94-7d2f-4790-a276-6ccfd4ea27b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameHydrocodone 100 DAU Calibrator, High Calibrator
Version Model Number0385
Catalog Number0385
Company DUNS840839190
Company NameLIN-ZHI INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
HIBCCB07603850 [Primary]

FDA Product Code

DLJCalibrators, Drug Specific

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-10-15
Device Publish Date2016-07-05

Devices Manufactured by LIN-ZHI INTERNATIONAL, INC.

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