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Bio/Data Corp.

United StatesFDA applicant, unverified

Bio/Data Corp. is a medical device manufacturer, with 37 devices listed in FDA 510(k), EUDAMED and FDA GUDID (FDA Class II and I) as of 13 Nov 2026.

Devices
37

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA 510(k) 37
  • EUDAMED 1
  • FDA GUDID 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 35
  • FDA Class I 2

What Bio/Data Corp. makes

Bio/Data Corp. manufactures in vitro diagnostic (IVD) reagents and accessories for platelet function testing, including ristocetin cofactor activity assays for von Willebrand factor, platelet aggregation reagents, nephelometry/turbidimetry kits, and single-use assay containers. Their portfolio also includes consumables like magnetic stirring rods, medical printer paper, and sample tubes, as well as software and analysers for platelet aggregation studies.

The company’s devices are regulated under FDA classifications, including Class I and Class II, with submissions recorded in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The products are listed under US jurisdiction.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue37

Newest first, rows 1-37 of 37

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  • Barbital Saline Buffer Ref K761170

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

  • Thrombin Clotting Time Ref K811109

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

  • Arachidonic Acid Ref K811290

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

  • Beta/Pak Ref K790769

    Active Regimes: CE IVDR 510(k) Registry: EUDAMED510(k)GUDID Class:II

  • Aggrecetin Ref K760893

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

  • Imidazole Buffer (0.05M) Ref K761175

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

  • Thrombokinetic Fibrinogen Assay Ref K792563

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

  • Microsample Coagulation Analyser Model 110P Ref K854546

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

  • Thrombinex Bovine Thrombin Ref K845000

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

  • Von Willebrand Factor Assay Ref K802356

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

  • Platelet Aggregation Profiler Model Pap-4C Ref K893650

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

  • Calcium Chloride Ref K853246

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

  • Microsample Coagulation Analyzer, Model Mca 310-C Ref K001891

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

  • Citrex H Ref K853897

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

  • Calcium Chloride (0.025M) Ref K761176

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

  • Von Willebrand Fac. Defic. Abnormal Control Plasma Ref K860751

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

  • Physiologic Saline (0.85%) Ref K761174

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

  • Citrex I Ref K853076

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

  • Hpc Tm (Heparinized Plasma Control) Ref K770188

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

  • Reptilase -Pc Ref K843207

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

  • Plastinex Ref K852484

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

  • Citrex Iii Ref K853078

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

  • Sodium Citrate Ref K761177

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

  • Thrombolytic Activity Test Ref K834301

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

  • Low Fibrinogen Control Ref K812108

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

  • Citrex Ii Ref K853077

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

  • Veronal Buffer Ref K761171

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

  • Tris Buffered Saline Ref K761172

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

  • Microsample Coagulation Analyser, Model 110WP Ref K860342

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

  • Platelet Aggregation Profiler #pap-4 Ref K821005

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

  • Tris Buffered Ref K761173

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

  • Kinetic Fibrinogen Assay Ref K881150

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

  • Tpc-Lyophilized Pooled Human Plasma Ref K761091

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

  • Microsample Coagulation Analyzer Ref K943153

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

  • Quan-8 Mult-Comp Factor Viii Assay Kit Ref K761058

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

  • Platelet Extract Reagent Ref K873382

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

  • Cephalinex Activated Ptt Reagent Ref K852195

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

Rows 1-37 of 37

Frequently asked questions

How many devices does Bio/Data Corp. have in the registry?

The registry currently lists 37 devices for Bio/Data Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bio/Data Corp.'s devices?

Among its 37 most recently registered devices, Bio/Data Corp. has devices listed in EUDAMED (1 device), FDA 510(k) (37 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Bio/Data Corp.'s devices fall under?

Among its 37 most recently registered devices, the classes recorded for Bio/Data Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Bio/Data Corp. in the registry?

The most recently registered devices listed for Bio/Data Corp. include BARBITAL SALINE BUFFER, THROMBIN CLOTTING TIME, ARACHIDONIC ACID and BETA/PAK.

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