ENBREL
etanercept
IMMUNEXPRESS, INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016504919 | 3016504919 | IMMUNEXPRESS, INC | 1 | N | 2026-01-01 | 425 Pontius Avenue North Suite 470 Seattle WA US 98109 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 300982 | 1471855413 | K232095 | SeptiCyte RAPID | PRE | 2023-12-15 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PRE | 1 | 2023-12-15 |
NDC#
PMN#
SeptiCyte RAPID
Immunexpress, Inc.
SeptiCyte RAPID
Immunexpress, Inc.
SeptiCyte LAB
IMMUNEXPRESS, INC.
HUMAN C-PEPTIDE REAGENTS
IMMUNEX RADIOCHEMICAL DIAGNOSTICS
Applications#
GUDID#
SeptiCyte RAPID [US IVD] - Sepsis Host Response US IVD EDTA PAXgene Variant Dispenser Box
2024-03-17
SeptiCyte RAPID [US IVD] - Sepsis Host Response US IVD EDTA PAXgene Variant Cartridge
2024-03-17
SeptiCyte RAPID - US IVD Dispenser Box (to contain 6 cartridges, each within a pouch)
2022-12-20
SeptiCyte RAPID - US IVD cartridge (+pouch)
2022-12-10