Diazyme Receives FDA 510(k) Clearance for HbA1c Assay – Block Scientific’s Mid-February Newsletter

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Diazyme Laboratories has announced that the U.S. FDA has granted 510(k) clearance to market its Direct HbA1c assay (Enzymatic, On-Board Lysis). This new enzymatic Direct HbA1c assay is the most convenient and accurate HbA1c assay available for use on general clinical chemistry analyzers. Measuring HbA1c allows clinicians to get an overall picture of what a patient’s average blood sugar levels have been over a period of months, and to track patients with diabetes.

Block Scientific is a global clinical laboratory equipment dealer based in New York, offering a range of lab equipment including analyzers, reagents, and drug test cups. Established in 1980, we offer both new and refurbished lab equipment from the top manufacturers in the industry. Our web store helps customers to easily search for the desired products.


Direct Enzymatic HbA1c test Kit (liquid stable), Lysis Buffer: 1 x 30 ml R1a: 1 x 16.8 ml R1b: 1 x 7.2 ml R2: 1 x 10 ml

Direct Enzymatic HbA1c Two (2) Level Calibrator Set (Lyophilized), Cal: 2 x 0.5 ml

Diazyme Direct Enzymatic HbA1c for SMART Analyzer (liquid stable), 20 x (Lysis Buffer: 0.25 mL, R1a: 0.7 mL, R2: 0.24 mL) R1b: 1 x 5 mL 1 x RFID Card

Direct Enzymatic HbA1c Two (2) Level control Set (lyophilized), Con: 2 x 0.5 ml

Diazyme Direct HBA1C Assay OBL, Kit

Diazyme Direct HBA1C Assay OBL, CON SET, 2 x 0.5 mL

Direct HBA1C Assay OBL, Cal Set

Siemens RAPIDPoint 500 System

Diazyme Smart 700/340 Analyzer


$187.00/Month with Installation, Training, Delivery and $2,000.00 Reagent Credit

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