Lp (a) Lipoprotein AU-204B

Lp (a) Lipoprotein AU
CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit - AU-204B

Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen, using a nephelometry/turbidimetry method.

Environmental Conditions

Special Storage Condition, Specify

Reagent is stable when stored unopened at 2-8° C until expiration date.

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

Total Volume: 45 Milliliter

Total Volume: 15 Milliliter

Kit contains 3 R1 and 3 R2 bottles

Total Volume: 45 Milliliter
Total Volume: 15 Milliliter
Kit contains 3 R1 and 3 R2 bottles

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DFC

Device Name: Lipoprotein, Low-Density, Antigen, Antiserum, Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: IM

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: 866.5600

Third Party Flag: Y

Medical Specialty: IM

Device Identifiers

Device Id: 00817302022308

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