Tina-quant Complement C4 Ver.2 08105545190

GUDID 07613336133606

Roche Diagnostics GmbH

Complement components C4/C4c IVD, kit, nephelometry/turbidimetry
Primary Device ID07613336133606
NIH Device Record Key8edad7d1-26b7-4c57-a67d-98d0c46e4079
Commercial Distribution StatusIn Commercial Distribution
Brand NameTina-quant Complement C4 Ver.2
Version Model Number08105545190
Catalog Number08105545190
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
GS107613336133606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DBICOMPLEMENT C4, 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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