HemosIL Homocysteine

Primary DI

08426950453024

Basic UDI-DI Code

842695045302478

Reference

0020007800

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Instrumentation Laboratory Company

Buffer: 2 vials x 9 mL of PBS (phosphate buffer solution) with preservative. Active ingredient: none. Reductant: 2 vials x 2 mL of adenosine and Tris (2-carboxyethyl) phosphine (TCEP) solution in Bis-Tris buffer with preservative. Active ingredient: none. Enzyme: 2 vials x 2 mL of recombinant S-adenosyl-L-homocysteine-hydrolase (SAHH) solution in phosphate buffer with stabilizer and preservative. Active ingredient: < 90 IU/mL recombinant S-adenosyl-L-homocysteine-hydrolase (SAHH). Conjugate: 2 vials x 2.5 mL of conjugate solution in PBS (phosphate buffer solution) with stabilizer and preservative. Active ingredient: none. a-SAH Latex Reagent: 2 vials x 2 mL of a lyophilized suspension of polystyrene latex particles coated with an anti S-adenosyl-L-homocysteine (SAH) monoclonal antibody in buffer containing bovine serum albumin and 0.02% Bronidox™ as a preservative. Active ingredient: < 0.1 % (w/w) chloromethyl polystyrene latex coated with monoclonal antibody. Calibrator: 2 vials x 1 mL of S-adenosyl-L-homocysteine (SAH) in PBS (phosphate buffer solution) with preservative. Active ingredient: < 0.01 % (w/w) S-adenosyl-L-homocysteine.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).