This page includes the latest FDA filings for Immunodiagnostic Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Immunodiagnostic Systems Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 2087498 |
| FEI Number | 3004046329 |
| Name | IMMUNODIAGNOSTIC SYSTEMS INC. |
| Owner & Operator | IMMUNODIAGNOSTIC SYSTEMS LTD. |
| Contact Address | 10 DIDCOT WAY BOLDON BUSINESS PARK BOLDON COLLIERY GB-NOTA NE35 9PD GB |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 948 Clopper Rd Gaithersburg Gaithersburg, MD 20878 US |
Device Company | Device | Date |
|---|---|---|
IMMUNODIAGNOSTIC SYSTEMS, INC. | IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET | 2010-06-25 |
| NCAGE Code | 43CY7 | IMMUNODIAGNOSTIC SYSTEMS INC.!DBA IDS |
| CAGE Code | 43CY7 | IMMUNODIAGNOSTIC SYSTEMS INC. IDS |
| S.A.M. Registration | 43CY7 [135835374] | IMMUNODIAGNOSTIC SYSTEMS INC. IDS |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020062745433 | Anvers,Belgium -> Baltimore, Maryland | PIECES 3 PALLETS CONTAINING 896 PCS IDS-ISYS CUVETTES LOT NOS. 47921,51921, 45931, 50931 10 PALLETS CONTAINING 1080 PCS IDS-ISYS SYSTEM | 2648 PCS |
| 2020031010473 | Anvers,Belgium -> Baltimore, Maryland | PCS 5 PALLETS CONTAINING 1168 PCS IDS-ISYS CUVETTES LOT NOS. 29931 AND 31931 4 PALLETS CONTAINING 432 PCS IDS-ISYS SYSTEM LIQUID (SYST.I) | 15 PCS |
| 2019093064469 | Anvers,Belgium -> Baltimore, Maryland | PCS IDS-ISYS CUVETTES PALLETS CONSISTING OF 2 PALLETS CONTAINING 960 PCS IDS-ISYS CUVETTES LOT NOS 04921/10931 6 PALLETS CONTAINING 648 PCS IDS-ISYS SYSTEM | 15 PCS |
| 2019031948872 | Anvers,Belgium -> Baltimore, Maryland | X 40REEFER CONTAINER STC CONTAIN 4 PALLETS CONTAINING 960 PCS IDS-ISYS CUVETTES LOT NOS 34821/34811 6 PALLETS CONTAINING 648 PCS IDS-ISYS SYSTEM | 1 PCS |
| 2018101532807 | Anvers,Belgium -> Baltimore, Maryland | 1440 PCS IDS-ISYS CUVETTES CONTAINING 6 PALLETS CONTAINING 1440 PCS IDS-ISYS CUVETTES LOT NO. 9821/12821/7831 6 PALLETS CONTAINING 648 PCS IDS-ISYS-SYSTEM LIQUID (SYST.I) LOT NUMBER | 20 PCS |
| 2018100863713 | Anvers,Belgium -> Baltimore, Maryland | 1440 PCS IDS-ISYS CUVETTES CONTAINING 6 PALLETS CONTAINING 1440 PCS IDS-ISYS CUVETTES LOT NO. 921/12821/7831 6 PALLETS CONTAINING 648 PCS IDS-ISYS-SYSTEM LIQUID (SYST.I) LOT NUMBER | 20 PCS |
| 2018050727765 | Anvers,Belgium -> Baltimore, Maryland | DS-ISYS CUVETTES PALLETS CONTAINING 6 PALLETS CONTAINING 1344 PCS IDS-ISYS CUVETTES LOT NO.S 48731/46711/ 46721 6 PALLETS CONTAINING | 20 PCS |