Pointe Direct Bilirubin Reagent packaged for use on the Mindray BA800. 8 x 18ml R1, 7 x 6ml R2. For the quantitative determination of direct bilirubin in serum. For in vitro diagnostic use only.

Pointe Direct Bilirubin Reagent packaged for use on the Mindray BA800. 8 x 18ml R1, 7 x 6ml R2. For the quantitative determination of direct bilirubin in serum. For in vitro diagnostic use only.
Pointe Direct Bilirubin Reagent - 16-HB936-186

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of conjugated (direct) bilirubin in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CIG

Device Name: Diazo Colorimetry, Bilirubin

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 862.1110

Third Party Flag: Y

Medical Specialty: CH

Device Id: 00811727016133

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