Buprenorphine 5 Qualitative Calibrator Set 08356661190

GUDID 00850624008070

BUP 5 Cutoff Calibrator 5 ng/mL (1 x 5 mL).

LIN-ZHI INTERNATIONAL, INC.

Buprenorphine IVD, calibrator
Primary Device ID00850624008070
NIH Device Record Keya1915dad-3a5a-48a4-902d-990e92d201cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameBuprenorphine 5 Qualitative Calibrator Set
Version Model Number08356661190
Catalog Number08356661190
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850624008070 [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 Number4
Public Version Date2018-10-15
Device Publish Date2018-04-20

Devices Manufactured by LIN-ZHI INTERNATIONAL, INC.

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