FDA.report

Elecsys PreciControl Anti-HBc

Primary DI
04015630923045
Brand
Elecsys PreciControl Anti-HBc
Company
Roche Diagnostics GmbH
Model
04927931160
Catalog number
04927931160
Published
2014-09-10
Public version status
Update
Distribution status
Not 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
LOMTest, hepatitis b (b core, be antigen, be antibody, b core igm)

Product Code Classifications

CodeDeviceSpecialtyClass
LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)Microbiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04015630923045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04015630923045040156309230454015630923045

GMDN Terms

TermDefinition
Hepatitis B virus core total antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis B virus core antigen in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
315028860
Device count
1
DM exempt
false
Premarket exempt
false
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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