Shield Diagnostics, Ltd.
Medical device manufacturer in Dundee, GB.
27510(k) clearances
0PMA approvals
0recalls
Device types
- MID System, Test, Anticardiolipin Immunological 3
- GGP Test, Qualitative And Quantitative Factor… 3
- LJM Antinuclear Antibody (Enzyme-Labeled)… 2
- LKP Anti-Sm Antibody, Antigen And Control 2
- LKO Anti-Rnp Antibody, Antigen And Control 2
- LKJ Antinuclear Antibody, Antigen, Control 2
- LLL Extractable Antinuclear Antibody, Antigen… 2
- MOB Test System, Antineutrophil Cytoplasmic… 2
- JZO System, Test, Thyroid Autoantibody 2
- KTL Anti-Dna Indirect Immunofluorescent Solid… 1
- DHN Antinuclear Antibody, Indirect… 1
- DBM Antimitochondrial Antibody, Indirect… 1
- JNB Ninhydrin And L-Leucyl-L-Alanine… 1
- DBL Multiple Autoantibodies, Indirect… 1
- LYR Helicobacter Pylori 1
- MSV System,Test,Antibodies,B2 - Glycoprotein I… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K000398 | Shield Von Willebrand Factor Activity Elisa, Model FVWF 200GGP · Traditional | 04/17/2000SE |
| K982879 | Shield Diastat ANTI-B2 Glycoprotein 1 Igg (Elisa) AssayMSV · Traditional | 10/15/1998SE |
| K980885 | Shield Activated Factor Xii (Elisa) AssayGGP · Traditional | 08/21/1998SE |
| K972981 | Shield HELICO-G2 Elisa KitLYR · Traditional | 03/17/1998SE |
| K962825 | Shield Von Willebrand Factor Activity (Elisa) AssayGGP · Traditional | 11/15/1996SE |
| K963525 | Diastat Anti-Glomerular Basement Membrane KitDBL · Traditional | 11/07/1996SE |
| K961515 | Quantase Phenylalanine AssayJNB · Traditional | 06/12/1996SE |
| K955303 | Diastat Anti-Cardiolipin KitMID · Traditional | 05/30/1996SE |
| K952183 | Diastat Anti-Thyroglobulin KitJZO · Traditional | 06/30/1995SE |
| K951487 | Diastat Anti-Thyroid Peroxidase KitJZO · Traditional | 06/30/1995SE |
| K943630 | Diastat Anti-Mpo (Panca) KitMOB · Traditional | 03/06/1995SE |
| K942813 | Diastat ANTI-PR3 (C-Anca) KitMOB · Traditional | 03/06/1995SE |
| K944505 | Diastat Ena Single Well Screen KitLLL · Traditional | 11/21/1994SE |
| K932876 | Diastat Anti-Nuclear Antibody (Ana) KitLKJ · Traditional | 11/15/1993SE |
| K932877 | Diastat Anti-Centromere KitLLL · Traditional | 10/15/1993SE |
| K923886 | Diastat Total Anti-Cardiolipin KitMID · Traditional | 09/25/1992SE |
| K921265 | Diastat Anti-Cardiolipin KitMID · Traditional | 08/03/1992SE |
| K920616 | Diastat Anti-Histone KitLJM · Traditional | 07/14/1992SE |
| K921183 | Diastat Anti-Mitochondrial Antibody KitDBM · Traditional | 06/19/1992SE |
| K912292 | Diastat ANTI-JO-1 KitDHN · Traditional | 07/30/1991SE |
| K912291 | Distat ANTI-SCL-70 KitLKJ · Traditional | 07/30/1991SE |
| K905386 | Distat Anti-Dsdna KitKTL · Traditional | 12/13/1990SE |
| K905194 | Diastat Anti-Ro (Ss-A)LKO · Traditional | 12/13/1990SE |
| K905193 | Diastat Anti-La (Ss-B)LKO · Traditional | 12/13/1990SE |
| K905192 | Diastat Anti-Sm/RnpLKP · Traditional | 12/07/1990SE |
| K905191 | Diastat Anti-SmLKP · Traditional | 12/07/1990SE |
| K905190 | Diastat Ena ProfileLJM · Traditional | 12/07/1990SE |