VITROS XT Chemistry Products TRIG-CHOL Slides

VITROS XT Chemistry Products TRIG
VITROS - 6844292

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CDT

Device Name: Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

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: 862.1705

Third Party Flag: N

Medical Specialty: CH

Code: CHH

Device Name: Enzymatic Esterase--Oxidase, Cholesterol

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: 862.1175

Third Party Flag: N

Medical Specialty: CH

Device Id: 10758750031764

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

Device Id: 20758750031761

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10758750031764

Package Quantity: 30

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case