The AMH Control Level 1 (AMH10509) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 1 (AMH10509) is assayed with target values and is suitable for use on automated analysers. The AMH Control Level 1 (AMH10509) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.

The AMH Control Level 1 (AMH10509) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti
AMH CONTROL LEVEL 1 (AMH CONTROL 1) - AMH10509

A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of anti-Mullerian hormone (AMH) in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JJX

Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1660

Third Party Flag: N

Medical Specialty: CH

Device Id: 05055273217773

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