Tina-quant Ferritin Gen.4 08057648190

GUDID 07613336121238

Roche Diagnostics GmbH

Ferritin IVD, kit, nephelometry/turbidimetry
Primary Device ID07613336121238
NIH Device Record Key576d1255-307d-4d77-83ee-555f84a5b448
Commercial Distribution StatusIn Commercial Distribution
Brand NameTina-quant Ferritin Gen.4
Version Model Number08057648190
Catalog Number08057648190
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
GS107613336121238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DBFFERRITIN, 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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