HEMGENIX
etranacogene dezaparvovec
CSL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1410248 | 1410248 | CSL Behring LLC | 1 | Y | 2026-01-01 | 1201 N Kinzie Ave Bradley IL US 60915 |
| 3008814738 | 3008814738 | CSL PLASMA, INC. | 1 | N | 2026-01-01 | 900 Broken Sound Pkwy NW Suite 400 Boca Raton FL US 33487 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 148190 | 1284621847 | K951254 | SAFETYGLIDE NEEDLE | FMI | 1995-10-07 |
| 148190 | 1201039228 | K140136 | NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE | FOZ | 2014-02-14 |
| 148190 | 1637446463 | K133867 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) | FPA | 2014-02-05 |
| 148190 | 1281906100 | K063280 | INJEKT SYRINGE | FMF | 2006-11-17 |
| 148190 | 1817169638 | K031861 | MIX2VIAL TRANSFER DEVICE | LHI | 2003-07-29 |
| 145286 | 2053608088 | BK210650 | |||
| 145286 | 1409417425 | BK190430 | |||
| 145286 | 1696524462 | BK120002 |
Product Codes Associated With Registrations#
NDC#
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
HEMGENIX
etranacogene dezaparvovec
Zemaira
alpha-1-proteinase inhibitor human
PMN#
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
CSL Plasma
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
CSL Plasma
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
CSL Behring AG