- Physicians Office Resource

AMH – Atellica IM – RGT – 100T
Atellica IM AMH - 10998433

Device Description

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 a chemiluminescent immunoassay method. AMH is typically used as a marker for ovarian reserve.

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 00842768022401

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

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