Strip Description:  For the in vitro quantitative determination of HDL-Cholesterol in human plasma from whole blood samples.

Strip Description:  For the in vitro quantitative determination of HDL
SPOTCHEM™ II HDL-Cholesterol - 77122

A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple general clinical chemistry analytes, including electrolytes [e.g., sodium (Na+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine, liver enzymes [e.g. Lactate dehydrogenase (LDH), alkaline phosphatase (ALP)] and/or lipids and lipoproteins. It functions by measuring the amount of light reflected from strips or laminated film impregnated with dry reagents onto which a clinical specimen is placed. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: 00015482771225

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: 50015482771220

Device Type: Unit of Use

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