This page includes the latest FDA filings for Critical Care Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3015489752 |
| FEI Number | 3015489752 |
| Name | CRITICAL CARE DIAGNOSTICS, INC |
| Owner & Operator | Critical Care Diagnostics, Inc |
| Contact Address | 555 E Eliza St Schoolcraft MI 49087 US |
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 555 E Eliza St Suite A Schoolcraft, MI 49087 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
CRITICAL CARE DIAGNOSTICS, INC | STIC Intra-Compartmental Pressure Monitor System | 2019-02-21 |
| CRITICAL CARE DIAGNOSTICS, INC. | Presage ST2 Assay Kit | 2018-07-11 |
| CRITICAL CARE DIAGNOSTICS, INC. | EIA Test Kit | 2018-07-11 |
| CRITICAL CARE DIAGNOSTICS, INC. | PRESAGE ST2 Controls Kit | 2018-07-11 |
| CRITICAL CARE DIAGNOSTICS, INC. | EIA Test Kit | 2018-07-11 |
CRITICAL CARE DIAGNOSTICS, INC. (DBA CRITICAL DIAG | PRESAGE ST2 ASSAY | 2011-12-09 |
| NCAGE Code | 8DAE3 | CRITICAL CARE DIAGNOSTICS, INC.!DBA C2DX |
| NCAGE Code | 613R1 | CRITICAL CARE DIAGNOSTICS, INC.!DBA CRITICAL DIAGNOSTICS |
| CAGE Code | 613R1 | CRITICAL CARE DIAGNOSTICS, INC. CRITICAL DIAGNOSTICS |
| S.A.M. Registration | 8DAE3 [116981210] | CRITICAL CARE DIAGNOSTICS, INC. C2DX |
| DUNS | 116981210 | Critical Care Diagnostics, Inc. |
| SEC | 0001573075 | Critical Care Diagnostics, Inc. of DELAWARE |