Jas Diagnostics, Inc.
Jas Diagnostics, Inc. holds FDA 510(k) medical device clearances, first cleared 2000, most recent 2014, with 3 FDA device recalls on record.
Top product codes for Jas Diagnostics, Inc.
FDA recalls by Jas Diagnostics, Inc.
- Z-2656-2017 — Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
- Z-0827-2015 — Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
- Z-1873-2014 — Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Jas Diagnostics, Inc.
- K130915 — XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
- K080623 — CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
- K080618 — DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
- K022519 — LDL CHOLESTEROL (AUTOMATED)
- K021671 — JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
- K020454 — CHEMISTRY CALIBRATOR
- K020282 — JAS AMYLASE LIQUID REAGENT
- K013912 — CREATINE KINASE (CK-NAC)
- K013698 — AST (SGOT)
- K012332 — JAS CARBON DIOXIDE LIQUID REAGENT
- K012038 — JAS URIC ACID LIQUID REAGENT
- K011900 — GLUCOSE (HEXOKINASE)
- K011599 — ALKALINE PHOSPHATASE LIQUID REAGENT
- K011441 — JAS CALCIUM (ARSENAZO) REAGENT
- K003835 — JAS MAGNESIUM REAGENT
- K003912 — PHOSPHORUS REAGENT
- K003829 — TOTAL BILIRUBIN
- K003693 — DIRECT BILIRUBIN
- K003247 — CREATININE
- K003327 — ALBUMIN
Data sourced from openFDA. This site is unofficial and independent of the FDA.