Access AMH B13127

GUDID 15099590669263

The Access AMH assay is paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone (AMH) levels i

Beckman Coulter, Inc.

Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID15099590669263
NIH Device Record Key0fe7738b-ebe4-4776-beb9-342567602a5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess AMH
Version Model NumberB13127
Catalog NumberB13127
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590669263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PQOAnti-Müllerian Hormone Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-16
Device Publish Date2018-03-16

Devices Manufactured by Beckman Coulter, Inc.

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