Homocysteine (HYC) Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL

Homocysteine (HYC) Atellica IM
Atellica IM HCY MCM - 10995609

Device Description

A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of homocysteine in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

Store Upright, Do not freeze, Resuspend.

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: 00630414599328

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