FDA.reportPublic FDA data

ADVIA Centaur® EHIV

Primary DI
00630414511245
Brand
ADVIA Centaur® EHIV
Company
Siemens Healthcare Diagnostics Inc.
Model
10332613
Catalog number
1622429
Device description
HIV 1/O/2 Enhanced (EHIV) (1-pack) 200T Assay 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
MZFTest, Hiv Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZFTest, Hiv DetectionMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BP0500300
BP05003010
BP05003013
BP05003021
BP0500305
BP0500308

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BP0500300
BP05003010
BP05003013
BP05003021
BP0500305
BP0500308

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414511245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414511245006304145112456304145112450630414511245

GMDN Terms#

Term, Definition table
TermDefinition
HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

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Primary DI, Brand, Company table
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00608337001808OraQuick HIV Self-TestOrasure Technologies, Inc.MZF2024-09-05
00628451188186Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
00628451188193Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
00628451188209HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
10628451188213HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
10628451188220Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
10628451188237Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
10628451188244Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
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10628451188268HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
00628451188179Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-10
10628451188169Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-08
15099590745158ACCESS HIV Ag/Ab comboBeckman Coulter, Inc.MZF2024-03-15
00884999050853Alinity mABBOTT MOLECULAR INC.MZF2023-06-08
07613336215845Elecsys HIV DuoRoche Diagnostics GmbHMZF2022-09-22
00884999050402Alinity mABBOTT MOLECULAR INC.MZF2022-08-29
00875197006445cobas® NHP Negative Control KitRoche Molecular Systems, Inc.MZF2022-08-01
00811877011101Determine™ HIV–1/2 Ag/Ab Combo Alere Scarborough, Inc.MZF2022-01-13
00811877011125Determine™ HIV–1/2 Ag/Ab Combo Controls Alere Scarborough, Inc.MZF2022-01-13
00875197006483cobas HIV-1/HIV-2 Qualitative Control KitRoche Molecular Systems, Inc.MZF2021-12-14
00875197006407cobas® HIV-1Roche Molecular Systems, Inc.MZF2021-12-10
00875197006476cobas® HBV/HCV/HIV-1 Control KitRoche Molecular Systems, Inc.MZF2021-12-10
07613336170182Elecsys HIV combi PTRoche Diagnostics GmbHMZF2021-09-16
07613336170212Elecsys HIV combi PTRoche Diagnostics GmbHMZF2021-09-16
00630414301280Atellica IM CHIVSiemens Healthcare Diagnostics Inc.MZF2021-01-15
00607158000083DPP HIV-SyphilisChembio Diagnostic Systems Inc.MZF2020-12-29
00686597010198INSTI HIV-1/HIV-2 Antibody TestBiolytical Laboratories IncMZF2020-09-30
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