FDA.report

cobas omni Wash Reagent WASH)

Primary DI
00875197004472
Brand
cobas omni Wash Reagent WASH)
Company
Roche Diagnostics GmbH
Model
1.0
Catalog number
06997503190
Published
2015-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MZPASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS

Product Code Classifications

CodeDeviceSpecialtyClass
MZPAssay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C VirusMicrobiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00875197004472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197004472008751970044728751970044720875197004472

GMDN Terms

TermDefinition
Buffered wash solution IVD, automated/semi-automated systemA buffered wash solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315028860
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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