Lp(a) (Lipoprotein (a) 2 x 130 tests

Lp(a) (Lipoprotein (a) 2 x 130 tests
CAROLINA LIQUID CHEMISTRIES CORP.® LP(a) RGT. KIT BL-204 - BL204

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to low density lipoprotein (anti-LDL) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Environmental Conditions

Special Storage Condition, Specify

Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C

Special Storage Condition, Specify

Unopened reagents are stable to expiration date when stored at 2 to 8°C

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

Total Volume: 7 Milliliter

Kit contains 2 R1 bottles, 2 R2 bottles and 1 package insert

Total Volume: 18 Milliliter

Total Volume: 7 Milliliter
Kit contains 2 R1 bottles, 2 R2 bottles and 1 package insert
Total Volume: 18 Milliliter

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

Code: JIT

Device Name: Calibrator, Secondary

Device Class: 2

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: 862.1150

Third Party Flag: N

Medical Specialty: CH

Code: JJX

Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 862.1660

Third Party Flag: N

Medical Specialty: CH

Device Identifiers

Device Id: 00817302020137

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