FDA.reportPublic FDA data

ADVIA Centaur® Systems aHBs QC

Primary DI
00630414471860
Brand
ADVIA Centaur® Systems aHBs QC
Company
Siemens Healthcare Diagnostics Inc.
Model
10309020
Catalog number
1453546
Device description
Anti-HBs (aHBs) Quality Control Material Kit
Published
2014-09-24
Public version status
Update
Distribution status
Not 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)

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
P030029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030029000ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORSSiemens Healthcare Diagnostics2004-05-14LOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414471860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414471860006304144718606304144718600630414471860

GMDN Terms#

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

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27
00630414597508Atellica CH hsCRP Calibrator11099412110994122017-12-22
00630414597515Atellica CH CRP_2 Calibrator11099430110994302017-12-22
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414611297Atellica CH RCRP Cal11537245115372452024-02-02
00842768037726Dimension EXL LOCI Troponin I High Sensitive10471068104710682019-10-16
00630414596099Atellica CH Thc11097503110975032017-12-27
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase Reagents1031517814108202016-09-24
00630414595641Atellica CH PAmy11097622110976222017-12-21
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414653259Atellica CH Crea311537567115375672026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336160367Elecsys Anti-HBs IIRoche Diagnostics GmbHLOM2024-10-02
07613336230367Elecsys Anti-HBs IIRoche Diagnostics GmbHLOM2024-08-20
00380740160579AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740160593AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740161262AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740214289AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740214296AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740214302AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00630414637877Atellica IM HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2024-04-26
00630414561226ADVIA Centaur® HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00630414210766ADVIA Centaur® HBcT2 Quality Control KitSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00630414604138Atellica IM HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00630414604336Atellica IM HBcT2 QCSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00380740156992ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740157012ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740158187ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740163389ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740208462ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740208479ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740208486ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740171742ARCHITECTAbbott Ireland DiagnosticsLOM2023-01-06
00380740171759ARCHITECTAbbott Ireland DiagnosticsLOM2023-01-06
00380740173555AlinityAbbott Ireland DiagnosticsLOM2023-01-06
00380740173562AlinityAbbott Ireland DiagnosticsLOM2023-01-06
00842768022678Atellica IM aHBe2Siemens Healthcare Diagnostics Inc.LOM2022-05-05
07613336203606Elecsys Anti-HBc IIRoche Diagnostics GmbHLOM2022-04-11
07613336203613Elecsys Anti-HBc IIRoche Diagnostics GmbHLOM2022-04-11
07613336175293Elecsys HBsAg Confirmatory TestRoche Diagnostics GmbHLOM2022-01-26
00630414167923ADVIA Centaur aHBe2 50T KitSiemens Healthcare Diagnostics Inc.LOM2022-01-14
04015630940134Elecsys Anti-HBeRoche Diagnostics GmbHLOM2021-12-09