Intended for in vitro diagnostic (IVD) use to monitor the instrument’s response in detecting haemolyzed, icteric and lipemic samples.

Intended for in vitro diagnostic (IVD) use to monitor the instrument’s response in detecting haemolyzed, icteric and lipemic samples.
SERUM INDICES (SERUM INDICES) - SI10448

A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative indication of chromogens in a clinical specimen, using a spectrophotometry method. This test is typically used in the assessment of lipaemia, turbidity, icterus caused by bilirubin and/or haemolysis of red blood cells.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JJY

Device Name: Multi-Analyte Controls, All Kinds (Assayed)

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 Id: 05055273217025

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