Immunodiagnostics Systems Ltd
Medical device manufacturer in Boldon, GB.
1510(k) clearances
0PMA approvals
8recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaLLL · Traditional | 08/21/2026SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0045-2013 Class II | IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box…It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with… | 08/10/2012Terminated |
| Z-0044-2013 Class II | IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing…It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with… | 08/10/2012Terminated |
| Z-0043-2013 Class II | IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing…It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with… | 08/10/2012Terminated |
| Z-0042-2013 Class II | IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing…It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with… | 08/10/2012Terminated |
| Z-0041-2013 Class II | IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830.…It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with… | 08/10/2012Terminated |
| Z-0040-2013 Class II | IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in…It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with… | 08/10/2012Terminated |
| Z-0039-2013 Class II | IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box…It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with… | 08/10/2012Terminated |
| Z-0173-2009 | IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of…A small number of customers have experienced low absorbance values when using kits from this batch. | 08/02/2008Terminated |