Tina-quant CReactive Protein IV 07876432190

GUDID 04015630946853

Roche Diagnostics GmbH

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Primary Device ID04015630946853
NIH Device Record Key4b5b8df3-e657-4253-8b76-6a58315105ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameTina-quant CReactive Protein IV
Version Model Number07876432190
Catalog Number07876432190
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
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
GS104015630946853 [Primary]
GS104015630946853 [Primary]
GS104015630946853 [Primary]
GS104015630946853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DCNSYSTEM, TEST, C-REACTIVE PROTEIN
DCNSYSTEM, TEST, C-REACTIVE PROTEIN
DCNSYSTEM, TEST, C-REACTIVE PROTEIN
DCNSYSTEM, TEST, C-REACTIVE PROTEIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [Tina-quant CReactive Protein IV]

0401563094685307876432190
0401563094684607876424190
0401563094683907876033190

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