FDA.reportPublic FDA data

Access AMH

Primary DI
15099590669263
Brand
Access AMH
Company
Beckman Coulter, Inc.
Model
B13127
Catalog number
B13127
Device description
The Access AMH assay is paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and lithium heparin plasma using the Access Immunoassay Systems as an aid in the assessment of ovarian reserve in women presenting to fertility clinics.
Published
2018-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K170524000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170524000Access AMHBeckman Coulter, Inc.2017-11-13PQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590669263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959066926315099590669263

GMDN Terms#

Term, Definition table
TermDefinition
Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)A 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 an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16

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
00630414225692ADVIA Centaur AMH KitSiemens Healthcare Diagnostics Inc.PQO2023-07-05
00842768022401Atellica IM AMHSiemens Healthcare Diagnostics Inc.PQO2023-07-05
07613336166284Elecsys AMHRoche Diagnostics GmbHPQO2022-07-20
07613336166291Elecsys AMHRoche Diagnostics GmbHPQO2022-07-20
04015630940363Elecsys AMHRoche Diagnostics GmbHPQO2017-04-21
04015630946211Elecsys AMHRoche Diagnostics GmbHPQO2017-02-24