Affinity Biologicals Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3003485232
• FEI Number: 3003485232
• Name: AFFINITY BIOLOGICALS INC.
• Owner & Operator: AFFINITY BIOLOGICALS INC.
• Contact Address: 1348 SANDHILL DRIVE --; ANCASTER, ONTARIO CA-NOTA L9G 4V5 CA
• Official Correspondent:
  • Janet - Lepischak
  • 1-905-3049896-x
• US Agent:
  • Michael van der Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • usagent@ul.com
• Importing Logistics Registration:
  • Importer: 23 and Me
  • Address: 220 Penobscot Dr. ; Redwood City, CA 94063 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Accriva Diagnostics
  • Address: 6260 Sequence Drive ; San Diego, CA 92121 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Alnylam US Inc
  • Address: 300 Third Street ; Cambridge, MA 02142 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Applied StemCell
  • Address: 521 Cottonwood Drive ; Milpitas, CA 95035 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: ARL BioPharma Inc
  • Address: 840 Research Parkway Suite 546 ; Oklahoma City, OK 73104 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Aronora
  • Address: 4640 SW MacAdam Ave. Suite 200A ; Portland, OR 97239 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Batavia Biosciences
  • Address: 300 Trade Center ; Woburn, MA 01801 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Baxter Healthcare Corp
  • Address: 5067 W. San Fernando Road ; Los Angeles, CA 90039 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Baylor College of Medicine
  • Address: One Baylor Plaza, Roomn 630E ; Houston, TX 77030 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Bektor Corp
  • Address: 2600 S Parker Rd. ; Aurora, CO 80014 UNITED STATES
  • Importer Type: END USER
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1348 SANDHILL DRIVE ; ANCASTER Ontario, L9G 4V5 CA
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 10629009111103 Affinity Biologicals Inc	VisuCon-L Coag Screen ABN2 Plasma	2024-07-08
GUDID 10629009101104 Affinity Biologicals Inc	VisuCon-L Coag Screen ABN1 Plasma	2024-07-08
GUDID 10629009091108 Affinity Biologicals Inc	VisuCon-L Coag Screen N Plasma	2024-07-08
GUDID 10629009145016 Affinity Biologicals Inc	Sheep anti-human Factor XIII Analyte Specific Reagent	2022-10-03
GUDID 10629009140516 Affinity Biologicals Inc	Sheep anti-human Factor XIII Analyte Specific Reagent	2022-10-03
GUDID 10629009131101 Affinity Biologicals Inc	VisuCon-L(TM) Normal Control Plasma	2019-10-30
GUDID 10629009121102 Affinity Biologicals Inc	VisuCon-L(TM) Abnormal Control Plasma	2019-10-30
GGN AFFINITY BIOLOGICALS INC.	VisuCon-L Normal Control Plasma	2018-09-12
GGN AFFINITY BIOLOGICALS INC.	VisuCon-L Coag Screen N Plasma	2018-09-12
GGN AFFINITY BIOLOGICALS INC.	VisuCon-L Coag Screen ABN2 Plasma	2018-09-12
GGN AFFINITY BIOLOGICALS INC.	VisuCon-L Coag Screen ABN1 Plasma	2018-09-12
GGN AFFINITY BIOLOGICALS INC.	VisuCon-L Abnormal Control Plasma	2018-09-12
PMN K150144 | GGN AFFINITY BIOLOGICALS INC.	VisuCon-F Low Fibrinogen Control Plasma	2016-03-10
PMN K150144 AFFINITY BIOLOGICALS INC.	VisuCon-F Low Fibrinogen Control Plasma	2016-03-06
PMN K110432 | GGN AFFINITY BIOLOGICALS INC.	VisuCon-F Frozen Coag Screen N	2011-10-24
PMN K110432 | GGN AFFINITY BIOLOGICALS INC.	VisuCon-F Frozen Coag Screen ABN	2011-10-24
PMN K110432 AFFINITY BIOLOGICALS INC.	VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN	2011-10-20
PMN K091284 | JIX AFFINITY BIOLOGICALS INC.	VisuCon-F Frozen Normal Control	2009-10-29
PMN K091284 | JIX AFFINITY BIOLOGICALS INC.	VisuCon-F Frozen Abnormal Control	2009-10-29
PMN K091284 | JIX AFFINITY BIOLOGICALS INC.	VisuCal-F Frozen Calibrator Plasma	2009-10-29
PMN K091284 | GGN AFFINITY BIOLOGICALS INC.	VisuCon-F Frozen Normal Control	2009-10-29
PMN K091284 | GGN AFFINITY BIOLOGICALS INC.	VisuCon-F Frozen Abnormal Control	2009-10-29
PMN K091284 | GGN AFFINITY BIOLOGICALS INC.	VisuCal-F Frozen Calibrator Plasma	2009-10-29
PMN K091284 AFFINITY BIOLOGICALS INC.	VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA	2009-10-28
MVU AFFINITY BIOLOGICALS INC.	Sheep anti-FXIII-IG-ASR (SAFXIII-IG-ASR)	2007-01-16
MVU AFFINITY BIOLOGICALS INC.	Sheep anti-FVII-HRP-ASR (SAFVII-HRP-ASR)	2007-01-16
MVU AFFINITY BIOLOGICALS INC.	Sheep anti-FVII-AP-ASR (SAFVII-AP-ASR)	2007-01-16
MVU AFFINITY BIOLOGICALS INC.	Sheep anti-F8C-HRP-ASR (SAF8C-HRP-ASR)	2007-01-16
MVU AFFINITY BIOLOGICALS INC.	Goat anti-VWF-IG-ASR (GAVWF-IG-ASR)	2007-01-16
MVU AFFINITY BIOLOGICALS INC.	Goat anti-VWF-HRP-ASR (GAVWF-HRP-ASR)	2007-01-16
MVU AFFINITY BIOLOGICALS INC.	Goat anti-PS-IG-ASR (GAPS-IG-ASR)	2007-01-16
MVU AFFINITY BIOLOGICALS INC.	Goat anti-PG-AP-ASR (GAPG-AP-ASR)	2007-01-16
MVU AFFINITY BIOLOGICALS INC.	Goat anti-PC-IG-ASR (GAPC-IG-ASR)	2007-01-16
PMN K052825 AFFINITY BIOLOGICALS INC.	VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG	2006-01-20
PMN K052825 | GGP AFFINITY BIOLOGICALS INC.	VISULIZE FACTOR VIII ANTIGEN KIT	2005-07-20
PMN K051054 | GGP AFFINITY BIOLOGICALS INC.	VISULIZE FACTOR IX ANTIGEN KIT	2005-07-20
PMN K051054 AFFINITY BIOLOGICALS INC.	VISULIZE FACTOR IX ANTIGEN KIT	2005-06-29

Related Finance Registrations

NCAGE Code	L08P9	AFFINITY BIOLOGICALS INC
CAGE Code	L08P9	AFFINITY BIOLOGICALS INC
S.A.M. Registration	L08P9 [249373515]	AFFINITY BIOLOGICALS INC