cobas¿ 4800 System Control Diluent Kit 05235847190

GUDID 00875197003215

Roche Molecular Systems, Inc.

Nucleic acid extraction/isolation kit IVD
Primary Device ID00875197003215
NIH Device Record Keya158ec12-b3be-4bcd-ba9b-b9705d263aed
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas¿ 4800 System Control Diluent Kit
Version Model Number1.0
Catalog Number05235847190
Company DUNS071674100
Company NameRoche Molecular Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100875197003215 [Primary]

FDA Product Code

LSLDNA-REAGENTS, NEISSERIA

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-03-31

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