CalSet Androstenedione 07679866190

GUDID 07613336169315

Roche Diagnostics GmbH

Androstenedione IVD, calibrator
Primary Device ID07613336169315
NIH Device Record Key37882792-1e78-448c-8f6a-2e6f72ab457f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalSet Androstenedione
Version Model Number07679866190
Catalog Number07679866190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS107613336169315 [Primary]

FDA Product Code

JITCalibrator, secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-13
Device Publish Date2020-03-05

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