Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8032314

FEI Number

3002808140

Entity Name

AXIS-SHIELD DIAGNOSTICS, LTD.

City/State/Country

DUNDEE Scotland, GB

Establishment Address

LUNA PLACE, THE TECHNOLOGY PARK, DUNDEE Scotland DD2 1XA, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AXIS-SHIELD DIAGNOSTICS, LTD. (Owner Number: 8032314)

Owner / Operator Contact Address

LUNA PLACE, THE TECHNOLOGY PARK, DUNDEE, SCOTLAND, GB-NOTA DD2 1XA, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112443

PMA Number

N/A

All Registered Proprietary Names

Cholestech LDX Multianalyte Calibration Verification Cholestech LDX Multianalyte Controls (2x2mL) Cholestech LDX Multianalyte Controls (2x 250uL) ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) assay ARCHITECT Active-B12 (Holotranscobalamin) Alinity Active-B12 (Holotranscobalamin) ADVIA Centaur anti-CCP (aCCP) assay ADVIA Centaur anti-CCP (aCCP) Quality Controls ADVIA Centaur anti-CCP (aCCP) Master Curve Materials (MCM) 3-Reagent Homocysteine Assay for SYNCHRON and UniCel Alinity I 2nd Generation Testosterone Controls Alinity i Active-B12 (Holotranscobalamin) Controls Afinion HbA1c Control Atellica IM Lipopolysaccharide Binding Protein Quality Control Alere NT-proBNP for Alinity i Control ADVIA Centaur Lipopolysaccharide Binding Protein (LBP) Quality Control SMN 10995083 - ADVIA Centaur® IL6 Quality Control Material SMN 10995080 - ADVIA Centaur® IL6 Assay Atellica IM Interleukin-6 Quality Control Atellica IM Interleukin-6 (IL6) ABBOTT ARCHITECT 2nd Generation Testosterone Axis-Shield Active-B12 (Holotranscobalmin) ADVIA Centaur Erythropoietin (EPO) Assay (XP) Ortho Clinical Diagnostics Vitros Homocysteine Alere NT-proBNP for Alinity i Alinity I 2nd Generation Testosterone Calibrators Alinity i Active-B12 (Holotranscobalamin) Calibrators AFINION HbA1c Calibration Verification Alere NT-proBNP for Alinity i Calibrators ARCHITECT 2nd Generation Testosterone Alinity i 2nd Generation Testosterone Reagent Kit N Latex HCY ARCHITECT Anti-CCP Controls Alinity I Anti-CCP Controls Alinity I Anti-CCP Calibrators AXIS SHIELD Homocysteine Control Kit (FHCY200/ B08177) ABBOTT ARCHITECT Homocysteine Alinity i Active-B12 (Holotranscobalamin) ABBOTT ARCHITECT Active-B12 (Holotranscobalamin)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2026-03-18
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2018-01-08
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2025-09-09
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2016-08-08
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2012-06-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-06-29
QLC	Interleukin 6	Unknown	Class N	N/A	2021-01-09
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-09-20
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-09-20
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2012-09-20
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2013-05-14
GGT	Assay, Erythropoietin	Hematology	Class 2	864.7250	2019-08-26
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-01-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-01-11
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2013-01-11
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2026-05-05
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-06-29
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2016-07-13
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2023-03-09
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2023-03-09
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2023-03-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2018-11-13
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2018-11-13
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2004-04-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2004-04-26
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2004-04-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-04-28
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2008-04-28
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-04-28
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2012-01-16
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-01-16
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-01-16

Official Correspondent

No official correspondent registered.

US Agent Details

Danial Kirmani Business: Abbott Laboratories Email: danial.kirmani@abbott.com Phone: (224) 6686318

Related Public Records

Same Entity

AXIS-SHIELD DIAGNOSTICS, LTD.

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
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04
K060755	Roche Diagnostics Corp.	ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK	2006-04-10
K910343	Ciba Corning Diagnostics Corp.	CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY	1991-03-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2007	N/A	2	Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
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.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), 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 8032314. Last updated year: 2026. Please use registration number 8032314 when referencing this establishment in official correspondence.