Prealbumin 08252645190

GUDID 07613336147894

Roche Diagnostics GmbH

Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry
Primary Device ID07613336147894
NIH Device Record Key09339e9d-7804-4b6d-acc3-511487ecfdb8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrealbumin
Version Model Number08252645190
Catalog Number08252645190
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
GS107613336147894 [Primary]

FDA Product Code

JZJPREALBUMIN, ANTIGEN, ANTISERUM, CONTROL

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

On-Brand Devices [Prealbumin]

0761333614789408252645190
040156309288045950902190

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