A homocysteine test system is a device intended for the quantitative in vitro determination of homocysteine concentration in human serum.

A homocysteine test system is a device intended for the quantitative in vitro determination of homocysteine concentration in human serum.
HCY - HY4036

Device Description

A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of homocysteine in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

R1, R2 are stable on board the analyser for 28 days at approximately +10°C.

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: 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 Identifiers

Device Id: 05055273208894

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