FDA.report

MICROBACT GNB 12B STRIP (60 ID'S)

Primary DI
05032384127979
Brand
MICROBACT GNB 12B STRIP (60 ID'S)
Company
OXOID LIMITED
Model
MB1133A
Published
2022-12-04
Public version status
New
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
LQMGram Negative Identification Panel

Product Code Classifications

CodeDeviceSpecialtyClass
LQMGram Negative Identification PanelMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05032384127979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05032384127979050323841279795032384127979

GMDN Terms

TermDefinition
Multiple bacteria species culture isolate identification control IVD, kitA collection of reagents and other associated materials intended to be used to verify the performance of one or multiple biochemical tests used for the differentiation and/or identification of multiple bacteria species that have been isolated by culture from a clinical specimen.

Sterilization Methods

Method

Regulatory Flags

DUNS number
365355452
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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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