Tina-quant ß2-Microglobulin 08047499190

GUDID 07613336120002

Roche Diagnostics GmbH

Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry
Primary Device ID07613336120002
NIH Device Record Key3485f880-7bdf-4c81-b5ed-7bda3c316fdb
Commercial Distribution StatusIn Commercial Distribution
Brand NameTina-quant ß2-Microglobulin
Version Model Number08047499190
Catalog Number08047499190
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336120002 [Primary]

FDA Product Code

JZGSystem, test, beta-2-microglobulin immunological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-28

On-Brand Devices [Tina-quant ß2-Microglobulin]

0761333612000208047499190
0761333611999008047430190

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