Jas Diagnostic, Inc.

Also registered as Jas Diagnostics, Inc.

United StatesFDA applicant, unverified

Devices: 21
FDA recalls: 3

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Jas Diagnostic, Inc. makes

Jas Diagnostic, Inc. manufactures liquid reagents for clinical laboratory testing, including urea nitrogen (BUN) assays used to measure blood urea levels.

The company’s BUN reagent is classified as a Class II medical device in the U.S. and is listed under the FDA’s 510(k) clearance process. The product is intended for in vitro diagnostic use.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue21

Newest first, rows 1-21 of 21

Search and filter all 21 devices

Creatine Kinase (Ck-Nac) Ref K013912

Active Regimes: 510(k) Registry: 510(k) Class:II
Chemistry Calibrator Ref K020454

Active Regimes: 510(k) Registry: 510(k) Class:II
Albumin Ref K003327

Active Regimes: 510(k) Registry: 510(k) Class:II
Jas Magnesium Reagent Ref K003835

Active Regimes: 510(k) Registry: 510(k) Class:I
Glucose (Hexokinase) Ref K011900

Active Regimes: 510(k) Registry: 510(k) Class:II
Direct Bilirubin Ref K003693

Active Regimes: 510(k) Registry: 510(k) Class:II
Creatinine Ref K003247

Active Regimes: 510(k) Registry: 510(k) Class:II
Phosphorus Reagent Ref K003912

Active Regimes: 510(k) Registry: 510(k) Class:I
Jas Carbon Dioxide Liquid Reagent Ref K012332

Active Regimes: 510(k) Registry: 510(k) Class:II
Xl-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent Pack Ref K130915

Active Regimes: 510(k) Registry: 510(k) Class:I
Ast (Sgot) Ref K013698

Active Regimes: 510(k) Registry: 510(k) Class:II
Cholesterol Oxidase Jase, And Glycerol Inase Triglycerides, Model Na Ref K080623

Active Regimes: 510(k) Registry: 510(k) Class:I
Ldl Cholesterol (Automated) Ref K022519

Active Regimes: 510(k) Registry: 510(k) Class:I
Direct HBA1C, Fructosamine, Glucose Oxidase Liquid Ref K080618

Active Regimes: 510(k) Registry: 510(k) Class:II
Alkaline Phosphatase Liquid Reagent Ref K011599

Active Regimes: 510(k) Registry: 510(k) Class:II
Jas Uric Acid Liquid Reagent Ref K012038

Active Regimes: 510(k) Registry: 510(k) Class:I
Jas Hdl Cholesterol (Automated) Reagent Ref K021671

Active Regimes: 510(k) Registry: 510(k) Class:I
Jas Amylase Liquid Reagent Ref K020282

Active Regimes: 510(k) Registry: 510(k) Class:II
Total Bilirubin Ref K003829

Active Regimes: 510(k) Registry: 510(k) Class:II
Jas Calcium (Arsenazo) Reagent Ref K011441

Active Regimes: 510(k) Registry: 510(k) Class:II
Urea Nitrogen (Bun) Liquid Reagent Ref K011596

Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-21 of 21

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

2017 1
2018 0
2019 0
2020 0
2021 0
2022 0
2023 0
2024 0
2025 0
2026 0

2 initiated before 2017

2017
- 21 Apr 2017 Z-2656-2017 Class II Terminated May result in elevated platelet backgrounds during routine startup/background checks. Distribution: AL, AR, CA, FL, GA, IA, IN, LA, MA, MN, MO, NC, NE, NY, SC, TN, TX, and Puerto Rico United Arab Emirates, Bolivia,…
  Full distribution text
  AL, AR, CA, FL, GA, IA, IN, LA, MA, MN, MO, NC, NE, NY, SC, TN, TX, and Puerto Rico United Arab Emirates, Bolivia, Republic of C¿te dIvoire, Colombia, Costa Rica, Ecuador, Egypt, Indonesia, Iraq, Italy, Korea, Mexico, Russia, Philippines, Slovenia, Tunisia, Venezuela, and Vietnam
  Submission number: K071562
2014
- 23 Oct 2014 Z-0827-2015 Class II Terminated Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range. Distribution: Worldwide Distribution -- US, including the states of NV, TN, TX, FL, GA, NY, NC, CA, MN, OR and Puerto Rico; and, the…
  Full distribution text
  Worldwide Distribution -- US, including the states of NV, TN, TX, FL, GA, NY, NC, CA, MN, OR and Puerto Rico; and, the countries of France, Jamaica, Haiti, Cayman Islands, Trinidad & Tobago, and Ghana.
  Submission number: K011900
- 7 Apr 2014 Z-1873-2014 Class II Terminated JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications. Distribution: Worldwide Distribution - US including Puerto Rico and the states of CA, FL, TX, PA, GA, KY, MI, NY, OK, MN, TN, VA, NC,…
  Full distribution text
  Worldwide Distribution - US including Puerto Rico and the states of CA, FL, TX, PA, GA, KY, MI, NY, OK, MN, TN, VA, NC, NV, NJ and WV, and the countries of Barbados, Ghana, Trinidad, Tobago, Canada and Haiti.
  Submission number: K011900

Frequently asked questions

How many devices does Jas Diagnostic, Inc. have in the registry?

The registry currently lists 21 devices for Jas Diagnostic, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Jas Diagnostic, Inc.'s devices?

Among its 21 most recently registered devices, Jas Diagnostic, Inc. has devices listed in FDA 510(k) (21 devices).

What risk classes do Jas Diagnostic, Inc.'s devices fall under?

Among its 21 most recently registered devices, the classes recorded for Jas Diagnostic, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Jas Diagnostic, Inc.?

FDA recall records list 3 recalls initiated by Jas Diagnostic, Inc., the most recent initiated on 2017-04-21. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Jas Diagnostic, Inc. in the registry?

The most recently registered devices listed for Jas Diagnostic, Inc. include CREATINE KINASE (CK-NAC), CHEMISTRY CALIBRATOR, ALBUMIN and JAS MAGNESIUM REAGENT.

Generated automatically from registry data and not verified by a human reviewer.

At a glance

Market reach

What Jas Diagnostic, Inc. makes

Catalogue21

Creatine Kinase (Ck-Nac) Ref K013912

Chemistry Calibrator Ref K020454

Albumin Ref K003327

Jas Magnesium Reagent Ref K003835

Glucose (Hexokinase) Ref K011900

Direct Bilirubin Ref K003693

Creatinine Ref K003247

Phosphorus Reagent Ref K003912

Jas Carbon Dioxide Liquid Reagent Ref K012332

Xl-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent Pack Ref K130915

Ast (Sgot) Ref K013698

Cholesterol Oxidase Jase, And Glycerol Inase Triglycerides, Model Na Ref K080623

Ldl Cholesterol (Automated) Ref K022519

Direct HBA1C, Fructosamine, Glucose Oxidase Liquid Ref K080618

Alkaline Phosphatase Liquid Reagent Ref K011599

Jas Uric Acid Liquid Reagent Ref K012038

Jas Hdl Cholesterol (Automated) Reagent Ref K021671

Jas Amylase Liquid Reagent Ref K020282

Total Bilirubin Ref K003829

Jas Calcium (Arsenazo) Reagent Ref K011441

Urea Nitrogen (Bun) Liquid Reagent Ref K011596

FDA recalls3

Recalls initiated per year

Frequently asked questions