FDA.reportPublic FDA data

ADVIA Centaur AMH Kit

Primary DI
00630414225692
Brand
ADVIA Centaur AMH Kit
Company
Siemens Healthcare Diagnostics Inc.
Model
10998432
Catalog number
10998432
Device description
AMH - Centaur - RGT – 100T
Published
2023-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PQOAnti-Müllerian hormone test system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQOAnti-Müllerian Hormone Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221801000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221801000ADVIA Centaur® Anti-Müllerian Hormone (AMH)Siemens Healthcare Diagnostics, Inc.2023-06-02PQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414225692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414225692006304142256926304142256920630414225692

GMDN Terms#

Term, Definition table
TermDefinition
Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of anti-Mullerian hormone (AMH) in a clinical specimen, using a chemiluminescent immunoassay method. AMH is typically used as a marker for ovarian reserve.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+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
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15
00630414177021ADVIA Centaur® TSH10309958103099582016-09-24
00630414177038ADVIA Centaur® TSH10309959103099592016-09-24
00630414556093ADVIA Centaur® SHBG Calibrator10285318102853182016-09-24
00630414559704ADVIA Centaur® T3 MCM10361928103619282016-09-24
00630414574516ADVIA® Chemistry Hemoglobin A1c_3 Calibrators10491408104914082016-09-24
00630414579160ADVIA Centaur® iPTH10492369104923692016-09-24
00630414585345ADVIA Centaur® iPTH10493615104936152016-09-24
00630414585352ADVIA Centaur® iPTH10493616104936162016-09-24
00630414587486ADVIA Centaur® iPTH Calibrator10630628106306282016-09-24
00630414587882ADVIA Centaur® Systems VitD Calibrator10630911106309112016-09-24
00630414600611ADVIA® Chemistry Alkaline Phosphatase (ALP_2c) Reagents10916067109160672016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870023779AMH AccuLite CLIA Test System - 192 WellsMONOBIND, INC.PQO2024-09-13
00816870023786AMH AccuLite CLIA Test System - 96 WellsMONOBIND, INC.PQO2024-09-13
00816870023793AMH AccuBind ELISA Test System - 192 WellsMONOBIND, INC.PQO2024-09-13
00816870023809AMH AccuBind ELISA Test System - 96 WellsMONOBIND, INC.PQO2024-09-13
00842768022401Atellica IM AMHSiemens Healthcare Diagnostics Inc.PQO2023-07-05
07613336166284Elecsys AMHRoche Diagnostics GmbHPQO2022-07-20
07613336166291Elecsys AMHRoche Diagnostics GmbHPQO2022-07-20
15099590669263Access AMHBeckman Coulter, Inc.PQO2018-03-16
04015630940363Elecsys AMHRoche Diagnostics GmbHPQO2017-04-21
04015630946211Elecsys AMHRoche Diagnostics GmbHPQO2017-02-24