Axis-Shield Diagnostics Limited
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED SRN GB-MF-000001886
Axis-Shield Diagnostics Limited is a medical device manufacturer based in the United Kingdom, with 47 devices listed in FDA 510(k), EUDAMED and FDA GUDID (FDA Class II and I; EU Class C) and 5 FDA recalls as of 14 Nov 2026.
- Devices
- 47
- Registrations
- EUDAMED
- FDA recalls
- 50 ongoing since 2021 (3 open in total)
Registry facts
- Registries
- FDA 510(k) 28
- EUDAMED 15
- FDA GUDID 14
- Device classes
- FDA Class II 35
- EU Class C 6
- FDA Class I 4
- Top EMDN categories
- Reagents 6
- FDA recalls
- Sites and related companies
- Axis-Shield Diagnostics, Ltd. United Kingdom
- Identifiers
- EUDAMED SRN GB-MF-000001886
- DUNS 229062427
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA recalls
What Axis-Shield Diagnostics Limited makes
Axis-Shield Diagnostics Limited manufactures in vitro diagnostic (IVD) reagents, controls, kits, and calibrators for laboratory testing. Their products include homocysteine assay reagents and controls, B-type natriuretic peptide (BNP) and NT-proBNP immunoassay kits and controls, vitamin B12 reagents, and cyclic citrullinated peptide antibody (anti-CCP) enzyme immunoassay (EIA) kits. These devices are designed for use in clinical chemistry and immunology testing platforms, such as chemiluminescent and enzyme-linked assays.
The company’s portfolio is regulated under US FDA classifications, with devices falling into Class I and Class II categories. Products are listed via the FDA’s 510(k) and Unique Device Identifier (UDI) systems, ensuring compliance with US regulatory requirements. The manufacturer operates from the United States.
Catalogue
Search and filter all 47 devicesCompany details
- EUDAMED SRN
- GB-MF-000001886
- DUNS number
- 229062427
- EUDAMED status
- Active
- EUDAMED registered name
- Axis-Shield Diagnostics Ltd
- Registered address
- Luna Place, DD2 1XA, Dundee, United Kingdom (ex Northern Ireland)
- Website
- www.axis-shield.com/
- Phone
- +44 (0)1382 422 000
- PRRC contact
- Claire Dora
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 9 May 2031
BSI Group The Netherlands B.V. 2797 1 certificate
- IVDR 735869 Active
Quality management system EU IVDR
- Issued
- 30 Mar 2026
- Expires
- 9 May 2031
- Valid from
- 10 May 2026
FDA recalls
FDA recall records list 5 recalls initiated by Axis-Shield Diagnostics Limited, the earliest on 2005-11-11 and the most recent on 2019-09-16. By recorded status: 3 ongoing and 2 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 3
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 16 Sep 2019 Z-0742-2020 Class II Open since 2019 There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
- 16 Sep 2019 Z-0743-2020 Class II Open since 2019 There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
- 16 Sep 2019 Z-0744-2020 Class II Open since 2019 There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
2015
- 20 Mar 2015 Z-1946-2015 Class II Terminated Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
2005
- 11 Nov 2005 Z-0003-2007 Unclassified (pre-2012) Terminated The preservative sodium azide used in the Kit Negative Control (part number FCOM175) was at the wrong concentration - the Kit Negative Control contains 0.2% sodium azide rather than the intended 0.1%.
Full distribution text
- 11 Nov 2005 Z-0003-2007 Unclassified (pre-2012) Terminated The preservative sodium azide used in the Kit Negative Control (part number FCOM175) was at the wrong concentration - the Kit Negative Control contains 0.2% sodium azide rather than the intended 0.1%.
Sites
- Axis-Shield Diagnostics, Ltd. GBFEI 3002808140 0 devices
Frequently asked questions
How many devices does Axis-Shield Diagnostics Limited have in the registry?
The registry currently lists 47 devices for Axis-Shield Diagnostics Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Axis-Shield Diagnostics Limited's devices?
Among its 47 most recently registered devices, Axis-Shield Diagnostics Limited has devices listed in EUDAMED (15 devices), FDA 510(k) (28 devices) and FDA GUDID (14 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Axis-Shield Diagnostics Limited's devices fall under?
Among its 47 most recently registered devices, the classes recorded for Axis-Shield Diagnostics Limited's devices are Class I, Class II and IVDR Class C. Each device page shows its own class and authorisation.
Are there FDA recall records for Axis-Shield Diagnostics Limited?
FDA recall records list 5 recalls initiated by Axis-Shield Diagnostics Limited, the most recent initiated on 16 Sep 2019. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Axis-Shield Diagnostics Limited?
EUDAMED lists 1 certificate for Axis-Shield Diagnostics Limited (quality management system) under IVDR. The most recent was issued on 30 Mar 2026.
What are the newest devices from Axis-Shield Diagnostics Limited in the registry?
The most recently registered devices listed for Axis-Shield Diagnostics Limited include Axis-Shield, Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit FHRWR100, Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit FHRWR1000 and Alere NT-proBNP for Alinity Control Kit 04S7911.