5-DIAGNOSTICS

FDA Device Registration & Listing · CH-4051 Basel Basel-Landschaft, CH · Registration 3012289015

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012289015
FEI Number
3012289015
Entity Name
5-DIAGNOSTICS
City/State/Country
CH-4051 Basel Basel-Landschaft, CH
Establishment Address
Heuberg 7, CH-4051 Basel Basel-Landschaft 4051, CH
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
5-Diagnostics (Owner Number: 10094384)
Owner / Operator Contact Address
Heuberg 7, CH-4051 Basel, CH-BL 4051, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

DOAC-Remove 5-PLASMA Bivalirudin Control 5-PLASMA Bivalirudin Calibrator 5-Plasma Bivalirudin AMR Verification Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PPM General Purpose Reagent Pathology Class 1 864.4010 2026-06-11
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2025-11-26
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2025-11-26
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2026-03-24

Official Correspondent

No official correspondent registered.

US Agent Details

Michele Washing Business: Aniara Diagnostica, Inc. Email: mwashing@aniara.com Phone: (513) 3422075

Related Public Records

Same Entity

5-Diagnostics
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K021022 Instrumentation Laboratory CO HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) 2002-05-14
K113211 Instrumentation Laboratory CO HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL 2012-01-04
K082859 Instrumentation Laboratory CO HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED 2008-12-19
K041905 Instrumentation Laboratory CO HEMOSIL CALIBRATION PLASMA 2004-09-28
K081103 Siemens Healthcare Diagnostics, Inc. LOCI THYROID CALIBRATOR WITH MODEL RC610 2008-05-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0514-2014 Instrumentation Laboratory Co. 2
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014 Instrumentation Laboratory Co. 2
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014 Instrumentation Laboratory Co. 2
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Z-0164-2015 Siemens Healthcare Diagnostics, Inc 2
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Z-0024-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012289015. Last updated year: 2026. Please use registration number 3012289015 when referencing this establishment in official correspondence.
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