cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test 09731261190

GUDID 00875197007299

Roche Molecular Systems, Inc.

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00875197007299
NIH Device Record Keyfe6258c6-ded5-4050-82e4-e2698f84de75
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
Version Model Number09731261190
Catalog Number09731261190
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 Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100875197007299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QOFMulti-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-05
Device Publish Date2025-05-28

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