Calbiotech Inc

FDA Filings

This page includes the latest FDA filings for Calbiotech 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: 2090110
• FEI Number: 3002346973
• Name: CALBIOTECH, INC.
• Owner & Operator: Erba USA, Inc.
• Contact Address: 1935 Cordell Court --; El Cajon CA 92020 US
• Official Correspondent:
  • DAVID - BARKA
  • x-619-7083999-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1935 Cordell Ct ; El Cajon, CA 92020 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
QKO CALBIOTECH, INC. [Erba USA, Inc.]	COVID-19 IgG ErbaLISA	2020-04-06
MRS CALBIOTECH, INC. [Erba USA, Inc.]	Calbiotech Cotinine ELISA	2017-04-14
PCL CALBIOTECH, INC. [Erba USA, Inc.]	Rubeola IgM ELIZA	2015-04-09
PCL CALBIOTECH, INC. [Erba USA, Inc.]	Measles IgM ELISA	2015-04-09
PCL CALBIOTECH, INC. [Erba USA, Inc.]	Measles IgG ELISA	2015-04-09
NGA CALBIOTECH, INC. [Erba USA, Inc.]	FSH ELISA	2015-04-09
NDR CALBIOTECH, INC. [Erba USA, Inc.]	Estradiol ELISA	2015-04-09
KLI CALBIOTECH, INC. [Erba USA, Inc.]	Total T4 CLIA	2015-04-09
KLI CALBIOTECH, INC. [Erba USA, Inc.]	Thyroxine (T4) ELISA	2015-04-09
JMR CALBIOTECH, INC. [Erba USA, Inc.]	Lysozyme ELISA	2015-04-09
JMD CALBIOTECH, INC. [Erba USA, Inc.]	Estrogens Total ELISA	2015-04-09
DAJ CALBIOTECH, INC. [Erba USA, Inc.]	Secretory IgA ELISA	2015-04-09
DAJ CALBIOTECH, INC. [Erba USA, Inc.]	Lysozyme ELISA	2015-04-09
CIZ CALBIOTECH, INC. [Erba USA, Inc.]	Dehydroepiandrosterone sulfate (DHEA-S) ELISA	2015-04-09
CIZ CALBIOTECH, INC. [Erba USA, Inc.]	Dehydroepiandrosterone sulfate (DHEA-S) CLIA	2015-04-09
CIZ CALBIOTECH, INC. [Erba USA, Inc.]	Androstenedione ELISA	2015-04-09
CIZ CALBIOTECH, INC. [Erba USA, Inc.]	Androstenedione CLIA	2015-04-09
JKD CALBIOTECH, INC. [Erba USA, Inc.]	C-Peptide ELISA	2007-12-11
GSM CALBIOTECH, INC. [Erba USA, Inc.]	Brucella IgM ELISA	2007-12-11
GSM CALBIOTECH, INC. [Erba USA, Inc.]	Brucella IgG ELISA	2007-12-11
CFP CALBIOTECH, INC. [Erba USA, Inc.]	Insulin ELISA	2007-12-11
MVU CALBIOTECH, INC. [Erba USA, Inc.]	Calbiotech SAR Various	2006-11-17
PPM CALBIOTECH, INC. [Erba USA, Inc.]	REAGENT	2006-11-16
PPM CALBIOTECH, INC. [Erba USA, Inc.]	GENERAL PURPOSE	2006-11-16
LJZ CALBIOTECH, INC. [Erba USA, Inc.]	Mycoplasma pneumoniae IgG ELISA	2006-07-20
LJZ CALBIOTECH, INC. [Erba USA, Inc.]	MYCOPLASMA PNEUMONIA IGG EN	2006-07-20
LJY CALBIOTECH, INC. [Erba USA, Inc.]	Mumps IgG ELISA	2006-07-20
LJY CALBIOTECH, INC. [Erba USA, Inc.]	MUMPS IGG ENZYME LINK	2006-07-20
CFT CALBIOTECH, INC. [Erba USA, Inc.]	Prolactin ELISA	2002-03-21
CFT CALBIOTECH, INC. [Erba USA, Inc.]	ELISA PROLACTIN (EA	2002-03-21
CFL CALBIOTECH, INC. [Erba USA, Inc.]	Human Growth Hormone (hGH) ELISA	2002-03-21
CEP CALBIOTECH, INC. [Erba USA, Inc.]	Luteinizing hormone (LH) ELISA	2002-03-21
CEP CALBIOTECH, INC. [Erba USA, Inc.]	FSH ELISA	2002-03-21
CEP CALBIOTECH, INC. [Erba USA, Inc.]	FSH CLIA	2002-03-21
JLS CALBIOTECH, INC. [Erba USA, Inc.]	Progesterone ELISA	2002-03-06
JLS CALBIOTECH, INC. [Erba USA, Inc.]	17-OH Progresterone ELISA	2002-03-06
CHP CALBIOTECH, INC. [Erba USA, Inc.]	Estradiol ELISA	2002-03-06
CGI CALBIOTECH, INC. [Erba USA, Inc.]	Free Estriol ELISA	2002-03-06
CGF CALBIOTECH, INC. [Erba USA, Inc.]	Estron ELISA	2002-03-06
CDP CALBIOTECH, INC. [Erba USA, Inc.]	Triiodothyronine, Free (FT3) ELISA	2002-03-06
CDP CALBIOTECH, INC. [Erba USA, Inc.]	Triiodothyronine, Free (FT3) CLIA	2002-03-06
CDP CALBIOTECH, INC. [Erba USA, Inc.]	Triiodothyronine (T3) ELISA	2002-03-06
CDP CALBIOTECH, INC. [Erba USA, Inc.]	Triiodothyronine (T3) CLIA	2002-03-06
CDP CALBIOTECH, INC. [Erba USA, Inc.]	T3 Uptake CLIA	2002-03-06

Related Finance Registrations

NCAGE Code	5J0T2	CALBIOTECH, INC.
CAGE Code	5J0T2	CALBIOTECH, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020041818320	La Spezia,Italy -> Long Beach, California	DIAGNOSTIC DEVICES	6 CTN
201911099462	Genova,Italy -> Long Beach, California	WELL STRIP ON SINGLEWELL HOLDING FRAMETRANSPA RENT PSHIGH BINDING CAPACITY	6 PKG
2019031620005	Livorno,Italy -> Long Beach, California	MACHINERY	3 CTN
2018060213258	Genova,Italy -> Long Beach, California	HIGH BINDING CAPACITY	6 PCS