Savyon Diagnostics L T D

FDA Filings

This page includes the latest FDA filings for Savyon Diagnostics L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 8030124
• FEI Number: 3003206361
• Name: SAVYON DIAGNOSTICS LTD.
• Owner & Operator: SAVYON DIAGNOSTICS, LTD.
• Contact Address: 3 HABOSEM ST. --; ASHDOD IL-NOTA 7761003 IL
• Official Correspondent:
  • ESTI - SAGIV
  • 972-885-62920-242
• US Agent:
  • Zohar Shipony
  • 408 8304534
  • zshipony@gmail.com
• Importing Logistics Registration:
  • Importer: GLYCOMINDS
  • Address: 4685 RUNWAY STREET SUITE J ; Simi Valley, CA 93063 UNITED STATES
  • Phone: 1 805 7912094
  • FAX: 1 805 7912086
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: IBL AMERICA
  • Address: 8201 Central Ave NE, Suite P ; Minneapolis, MN 55432 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Jant Pharmacal corporation
  • Address: 16255 Ventura Blvd Suite 505 ; Encino, CA 91436 UNITED STATES
  • Importer Type: Retailer
• Importing Logistics Registration:
  • Importer: Neuco
  • Address: 50 Place Cremazie West Suite 700 ; Montreal, H2P 2T4 CANADA
  • Importer Type: Wholesale distributor
  • Subdivision: CA-QC
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3 HABOSEM ST. ; ASHDOD, 7761003 IL
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 07290016332193 SAVYON DIAGNOSTICS LTD	Serum Diluent IgM B262-03M	2023-07-07
GUDID 07290013348494 SAVYON DIAGNOSTICS LTD	Bordetella immunology reagents IgM 2232-01	2023-07-07
GUDID 07290013348487 SAVYON DIAGNOSTICS LTD	Bordetella immunology reagents IgA 2233-01	2023-07-07
GUDID 07290013348470 SAVYON DIAGNOSTICS LTD	Conjugate IgM A232-12M	2023-07-07
GUDID 07290013348302 SAVYON DIAGNOSTICS LTD	Conjugate IgA A233-12M	2023-07-07
GUDID 07290016332636 SAVYON DIAGNOSTICS LTD	Bordetella Pertussis IgG A-2231-01M	2023-06-26
LXG SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	NanoCHIP XL	2016-05-16
LXG SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	NanoCHIP 400	2016-05-16
KTO SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	Analyte specific reagent	2014-09-03
MVU SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	IBDX plates, GAGA plates	2012-12-10
DGR SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	IBDX immunology control	2012-12-10
GOZ SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	SeroPertussis Toxin IgG	2009-12-20
GOZ SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	SeroPertussis Toxin IgA	2009-12-20
GOZ SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	SeroPertussis IgA/IgM	2009-12-20
GOZ SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	Bordetella Pertussis IgG	2009-12-20
PMN K010244 | CEP SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	OVULATION Predictor (OTC use)	2009-06-29
PMN K981084 | JXA SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	URISCREEN (UTI screening OTC use)	2009-06-24
PMN K915281 | LJC SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	SeroELISA Chlamydia IgG	2009-06-24
PMN K914327 | LJC SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	SeroELISA Chlamydia IgA	2009-06-24
PMN K910644 | LKH SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	IPAzyme Chlamydia IgG/IgA	2009-06-24
PMN K901975 | LKH SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	IPAzyme Chlamydia TRUE IgM	2009-06-24
PMN K882596 | LJZ SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	SeroMP Recombinant IgG, IgM, IgA	2009-06-24
PMN K882211 | JXA SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	URISCREEN (UTI screening)	2009-06-24
PMN K011551 | LCX SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	PREGNANCY test hCG (OTC use)	2009-06-24
LRF SAVYON DIAGNOSTICS LTD. [SAVYON DIAGNOSTICS, LTD.]	VAGINAL YEAST test (POC use)	2007-07-23
PMN K921045 SAVYON DIAGNOSTICS, LTD.	DIASLIDE URINE CULTURING DEVICE	1992-09-28
PMN K914327 SAVYON DIAGNOSTICS, LTD.	SEROELISA(TM) CHLAMYDIA IGA TEST KIT	1992-06-09
PMN K915281 SAVYON DIAGNOSTICS, LTD.	SEROLISA CHLAMYDIA IGG TEST KIT	1992-03-23
PMN K910644 SAVYON DIAGNOSTICS, LTD.	IPAZYME (TM) CHLAMYDIA IGG-IGA	1991-03-19
PMN K901975 SAVYON DIAGNOSTICS, LTD.	IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)	1991-03-08

Related Finance Registrations

NCAGE Code	2401A	SAVYON DIAGNOSTICS LTD
NCAGE Code	SB840	SAVYON DIAGNOSTICS LTD
CAGE Code	SB840	SAVYON DIAGNOSTICS LTD
CAGE Code	EX188	SAVYON DIAGNOSTICS LTD
CAGE Code	2401A	SAVYON DIAGNOSTICS LTD