Methadone Metabolite 100 DAU Calibrator, Low Calibrator 0202b

GUDID B0760202B0

5mL/bottle. Concentration: 50 ng/mL of EDDP.

LIN-ZHI INTERNATIONAL, INC.

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator
Primary Device IDB0760202B0
NIH Device Record Keye25df099-841a-45ad-88c4-53b461eca7ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameMethadone Metabolite 100 DAU Calibrator, Low Calibrator
Version Model Number0202b
Catalog Number0202b
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
HIBCCB0760202B0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number2
Public Version Date2019-10-28
Device Publish Date2018-09-17

Devices Manufactured by LIN-ZHI INTERNATIONAL, INC.

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