Drawbridge Health, Inc.

Address:620 Omni Industrial Blvd,Summerville,SC,29486,US

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Assay, Glycosylated Hemoglobin (LCP) (1) Capillary Blood Collection Device For Alternative Site Collection (PRJ) (1)

Premarket Exempt

Clear

OneDraw A1C Test System - 00086303000046 Catalog Number :

Device Description : The OneDraw™ A1C Test System is a single-use, sterile, capillary blood specimen The OneDraw™ A1C Test System is a single-use, sterile, capillary blood specimen collection, stabilization, and transportation system. The device incorporates lancets to make two small incisions in the skin and a vacuum to draw blood at the surface of the skin and through channels to deposit the blood onto collection and stabilization matrices. The collection kit is designed to facilitate in vitro laboratory testing of blood samples for clinical chemistry assays. OneDraw™ includes a collection device, transport sleeve, accessories, and instructions needed to collect, package, and mail the sample collection cartridge to the certified clinical laboratory for HbA1c testing.

Device Class :

Duns Number: 048087575

Premarket Exempt : No

Product Code : LCP, PRJ

Prescription Use : Yes

Device Count : 1

Previous 1 Next