FDA.reportPublic FDA data

ADVIA Centaur® HBc IgM

Primary DI
00630414470498
Brand
ADVIA Centaur® HBc IgM
Company
Siemens Healthcare Diagnostics Inc.
Model
10308978
Catalog number
504619
Device description
HBc IgM (aHBcM) Assay Kit - 100T
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LOMTest, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
SEIQualitative and Quantitative Hepatitis B Virus Antibody assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)Microbiology2
SEIQualitative And Quantitative Hepatitis B Virus Antibody AssaysMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030040002
P030040004
P030040005
P030040006
P030040008
P030040009

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030040002ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040004ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040005ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040006ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040008ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040009ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414470498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414470498006304144704986304144704980630414470498

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis B virus core antigen in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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15099590806347Access anti-HBc IgM QCBeckman Coulter, Inc.SEI2026-05-04
15099590806293Hepatitis B Virus core Total AntibodyBeckman Coulter, Inc.SEI2026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORBeckman Coulter, Inc.SEI2026-03-30
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