FDA.reportPublic FDA data

ARGENE® ADENOVIRUS R-gene KIT US

Primary DI
03573026403997
Brand
ARGENE® ADENOVIRUS R-gene KIT US
Company
BIOMERIEUX SA
Model
69-010B-US
Device description
ADENOVIRUS R-gene® KIT US is a RT-PCR test is to aid in the diagnosis of respiratory Adenovirus infection in humans in conjunction with other clinical and laboratory findings.
Published
2016-10-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OCCRespiratory Virus Panel Nucleic Acid Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCCRespiratory Virus Panel Nucleic Acid Assay SystemMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026403997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026403997035730264039973573026403997

GMDN Terms#

Term, Definition table
TermDefinition
Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Adenovirus in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-31 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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