FDA.reportPublic FDA data

Elecsys PreciControl HBsAg

Primary DI
04015630911059
Brand
Elecsys PreciControl HBsAg
Company
Roche Diagnostics GmbH
Model
11876309160
Catalog number
11876309160
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
Single use
true

Product Codes#

Code, Name table
CodeName
LOMTest, hepatitis b (b core, be antigen, be antibody, b core igm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P990012000
P990012001
P990012005
P990012006
P990012012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990012000ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAGRoche Diagnostics Corp.2001-06-01LOM
P990012001ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAGRoche Diagnostics Corp.2001-06-01LOM
P990012005ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAGRoche Diagnostics Corp.2001-06-01LOM
P990012006ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAGRoche Diagnostics Corp.2001-06-01LOM
P990012012ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAGRoche Diagnostics Corp.2001-06-01LOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630911059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630911059040156309110594015630911059

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus surface antigen 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 Hepatitis B virus surface antigen in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336160367Elecsys Anti-HBs IIRoche Diagnostics GmbHLOM2024-10-02
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