Repligen Corp

FDA Filings

This page includes the latest FDA filings for Repligen Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USA

NASDAQ

RGEN

DUNS 013308119

FDA Registration(s)

• Registration Number: 1625657
• FEI Number: 1625657
• Name: Repligen Corporation
• Owner & Operator: SPECTRUM LABORATORIES, INC.
• Contact Address: 18617 BROADWICK --; Rancho Dominguez CA 90220 US
• Official Correspondent:
  • Tejinder S Kohli
  • 1-310-6054497-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3400 ROYALTY ROW ; IRVING, TX 75062 US
• Establishment Type:
  • Manufacture Medical Device
  • Reprocess Single-Use Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
HST Repligen Corporation [SPECTRUM LABORATORIES, INC.]	AR 1712	2018-09-14
HST Repligen Corporation [SPECTRUM LABORATORIES, INC.]	AR 1652	2018-09-14
HST Repligen Corporation [SPECTRUM LABORATORIES, INC.]	AR 1651	2018-09-14
HST Repligen Corporation [SPECTRUM LABORATORIES, INC.]	AA-A-KIT10-A1	2018-09-14
KKX Repligen Corporation [SPECTRUM LABORATORIES, INC.]	Model 6177 Sterile Sleeve	2016-05-09
FQL Repligen Corporation [SPECTRUM LABORATORIES, INC.]	Stockinette	2016-04-20
PMN K923099 | IWQ Repligen Corporation [SPECTRUM LABORATORIES, INC.]	C-Arm Drape	2012-01-24
ITG Repligen Corporation [SPECTRUM LABORATORIES, INC.]	Stockinette	2011-09-07
PMN K934630 | KKX Repligen Corporation [SPECTRUM LABORATORIES, INC.]	EQUIPMENT DRAPE	2007-11-09
PMN K863872 | LPZ Repligen Corporation [SPECTRUM LABORATORIES, INC.]	SPECTRUM/HYDRO-MED	2007-10-12
KIC Repligen Corporation [SPECTRUM LABORATORIES, INC.]	HEEL/ELBOW CUSION, FLOTATION	1999-12-14
KIC Repligen Corporation [SPECTRUM LABORATORIES, INC.]	FLOTATION	1999-12-14
KIC Repligen Corporation [SPECTRUM LABORATORIES, INC.]	CUSHION	1999-12-14
GAX Repligen Corporation [SPECTRUM LABORATORIES, INC.]	STERILE ESMARCH BANDAGE	1999-12-14

Related Finance Registrations

NCAGE Code	1FHH9	REPLIGEN CORPORATION
CAGE Code	1FHH9	REPLIGEN CORPORATION
S.A.M. Registration	1FHH9 [13308119]	REPLIGEN CORPORATION
SEC	0000730272	REPLIGEN CORP of DELAWARE