FDA.report

McKesson

Primary DI
20612479225118
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
181-36025
Device description
Influenza A & B Test
Published
2017-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C

Product Code Classifications

CodeDeviceSpecialtyClass
GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, CMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20612479225118PrimaryGS10
10612479227351Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2061247922511820612479225118
1061247922735110612479227351

GMDN Terms

TermDefinition
Influenza A/B virus antigen IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of antigens from influenza A virus and/or influenza B virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
25
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
true
Sterilization required before use
false

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