# Shield Diagnostics, Ltd.

- Location (FDA's records): Dundee, GB
- FDA decisions: 27 (1990–2000): 27 510(k) clearances
- Product codes: MID (3), GGP (3), LLL (2), JZO (2), LJM (2), LKO (2), LKP (2), LKJ (2), MOB (2), DBL (1), LYR (1), JNB (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Corgenix, Inc.: 1 (https://510kreport.com/company/corgenix)
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)

## Its most-cited devices
- K000398: Shield Von Willebrand Factor Activity Elisa, Model FVWF 200 (2000), cited by 2

## Recent decisions
- K000398: Shield Von Willebrand Factor Activity Elisa, Model FVWF 200 (Apr 17, 2000)
- K982879: Shield Diastat Anti-B2 Glycoprotein 1 Igg (Elisa) Assay (Oct 15, 1998)
- K980885: Shield Activated Factor Xii (Elisa) Assay (Aug 21, 1998)
- K972981: Shield Helico-G2 Elisa Kit (Mar 17, 1998)
- K962825: Shield Von Willebrand Factor Activity (Elisa) Assay (Nov 15, 1996)
- K963525: Diastat Anti-Glomerular Basement Membrane Kit (Nov 7, 1996)
- K961515: Quantase Phenylalanine Assay (Jun 12, 1996)
- K955303: Diastat Anti-Cardiolipin Kit (May 30, 1996)

Source page: https://510kreport.com/company/shield-diagnostics