Shield Diagnostics, Ltd.
Dundee, GB
Shield Diagnostics, Ltd. appears in FDA device records in Dundee, GB. FDA records list 27 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Shield Diagnostics, Ltd. between 1990 and 2000. The busiest year on record is 1990, with 6. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 6 |
| 1991 | 2 |
| 1992 | 4 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 4 |
| 1996 | 4 |
| 1998 | 3 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K000398 | SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 | GGP | Substantially Equivalent | |
| K982879 | SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY | MSV | Substantially Equivalent | |
| K980885 | SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY | GGP | Substantially Equivalent | |
| K972981 | SHIELD HELICO-G2 ELISA KIT | LYR | Substantially Equivalent | |
| K962825 | SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY | GGP | Substantially Equivalent | |
| K963525 | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT | DBL | Substantially Equivalent | |
| K961515 | QUANTASE PHENYLALANINE ASSAY | JNB | Substantially Equivalent | |
| K955303 | DIASTAT ANTI-CARDIOLIPIN KIT | MID | Substantially Equivalent | |
| K952183 | DIASTAT ANTI-THYROGLOBULIN KIT | JZO | Substantially Equivalent | |
| K951487 | DIASTAT ANTI-THYROID PEROXIDASE KIT | JZO | Substantially Equivalent | |
| K943630 | DIASTAT ANTI-MPO (PANCA) KIT | MOB | Substantially Equivalent | |
| K942813 | DIASTAT ANTI-PR3 (C-ANCA) KIT | MOB | Substantially Equivalent | |
| K944505 | DIASTAT ENA SINGLE WELL SCREEN KIT | LLL | Substantially Equivalent | |
| K932876 | DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT | LKJ | Substantially Equivalent | |
| K932877 | DIASTAT ANTI-CENTROMERE KIT | LLL | Substantially Equivalent | |
| K923886 | DIASTAT TOTAL ANTI-CARDIOLIPIN KIT | MID | Substantially Equivalent | |
| K921265 | DIASTAT ANTI-CARDIOLIPIN KIT | MID | Substantially Equivalent | |
| K920616 | DIASTAT ANTI-HISTONE KIT | LJM | Substantially Equivalent | |
| K921183 | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT | DBM | Substantially Equivalent | |
| K912292 | DIASTAT ANTI-JO-1 KIT | DHN | Substantially Equivalent | |
| K912291 | DISTAT ANTI-SCL-70 KIT | LKJ | Substantially Equivalent | |
| K905386 | DISTAT ANTI-DSDNA KIT | KTL | Substantially Equivalent | |
| K905194 | DIASTAT ANTI-RO (SS-A) | LKO | Substantially Equivalent | |
| K905193 | DIASTAT ANTI-LA (SS-B) | LKO | Substantially Equivalent | |
| K905192 | DIASTAT ANTI-SM/RNP | LKP | Substantially Equivalent | |
| K905191 | DIASTAT ANTI-SM | LKP | Substantially Equivalent | |
| K905190 | DIASTAT ENA PROFILE | LJM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase
- LKOAnti-Rnp Antibody, Antigen And Control
- LKPAnti-Sm Antibody, Antigen And Control
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LKJAntinuclear Antibody, Antigen, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- LLLExtractable Antinuclear Antibody, Antigen And Control
- LYRHelicobacter Pylori
- DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
- MIDSystem, Test, Anticardiolipin Immunological
- JZOSystem, Test, Thyroid Autoantibody
- MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
- GGPTest, Qualitative And Quantitative Factor Deficiency
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain