For the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only.

For the direct quantitative determination of low density lipoprotein cholesterol (LDL
autoLDL - 12-L7574-162

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of low density lipoprotein (LDL) cholesterol lipid 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: MRR

Device Name: System, Test, Low Density, Lipoprotein

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: 862.1475

Third Party Flag: N

Medical Specialty: CH

Device Id: 00811727013637

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