Tina-quant IgM Gen.2 08057923190

GUDID 07613336121337

Roche Diagnostics GmbH

Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Primary Device ID07613336121337
NIH Device Record Key0c5264d6-e646-4c09-a728-d5dead736f12
Commercial Distribution StatusIn Commercial Distribution
Brand NameTina-quant IgM Gen.2
Version Model Number08057923190
Catalog Number08057923190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS107613336121337 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DAOIGM (MU CHAIN SPECIFIC), 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

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