LightCycler¿ MRSA Advanced Test¿ 05205727190

GUDID 00875197002973

Roche Molecular Systems, Inc.

MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00875197002973
NIH Device Record Keyd0cf4d76-f4f1-4aae-ab8c-72697948cf8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameLightCycler¿ MRSA Advanced Test¿
Version Model Number1.0
Catalog Number05205727190
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
GS100875197002973 [Primary]

FDA Product Code

NQXSYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-01-23
Device Publish Date2016-03-31

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