Liquid Stable 2-Part Homocysteine Reagent, intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Size: 1 x 50 mL, 1 x 7 mL, 2 x 3 mL

Liquid Stable 2
Pointe Scientific, Inc. - H7575-57

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of homocysteine in a clinical specimen, using a spectrophotometry method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LPS

Device Name: Urinary Homocystine (Nonquantitative) Test System

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 862.1377

Third Party Flag: Y

Medical Specialty: CH

Device Id: 00811727014573

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