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.

The Access AMH assay is paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti
Access AMH - B13127

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.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PQO

Device Name: Anti-Müllerian Hormone Test System

Device Class: 2

Physical State: In vitro diagnostic device, reagent

Definition: An Anti-Müllerian hormone test system is an in vitro diagnostic device intended to measure anti-Müllerian hormone in human serum and plasma. The test is intended to be used as an aid for assessing ovarian reserve in women.

Submission Type ID: 1

Review Panel: TX

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: mmunoassay, other

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Fertility, diagnosis

Regulation Number: 862.1092

Third Party Flag: N

Medical Specialty: CH

Device Id: 15099590669263

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A