Scantibodies Laboratory Inc

FDA Filings

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

Scantibodies Laboratory Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number2020808
FEI Number2020808
NameSCANTIBODIES LABORATORY, INC.
Owner & OperatorScantibodies Laboratory Inc.
Contact Address9336 Abraham Way --
Santee CA 92071 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9336 ABRAHAM WAY
SANTEE, CA 92071 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

Registration Number3002792284
FEI Number3002792284
NameLABORATORIOS SCANTIBODIES S.A. DE C.V.
Owner & OperatorScantibodies Laboratory Inc.
Contact Address9336 Abraham Way --
Santee CA 92071 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressCalle Los Vinedos #4100 Parque Industrial El Bajio CP 21430
TECATE Baja California, -- MX
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device
Company
DeviceDate
SCANTIBODIES LABORATORY, INC.
 Scantibodies Laboratory, Inc. 2019-12-23
SCANTIBODIES LABORATORY, INC.
 Scantibodies Laboratory, Inc. 2019-12-23
SCANTIBODIES LABORATORY, INC.
 Scantibodies Laboratory, Inc. 2019-12-23
SCANTIBODIES LABORATORY, INC. [Scantibodies Laboratory Inc.]
3KG6012019-06-05
SCANTIBODIES LABORATORY, INC.
 Scantibodies Laboratory, Inc. 2019-05-28
SCANTIBODIES LABORATORY, INC.
 Scantibodies Laboratory, Inc. 2019-05-28
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
Sofia Strep A+FIA(25T)2015-06-19
SCANTIBODIES LABORATORY, INC. [Scantibodies Laboratory Inc.]
Total Intact PTH Immunoradiometric (IRMA) Assay (Coated Tube)2014-05-21
SCANTIBODIES LABORATORY, INC. [Scantibodies Laboratory Inc.]
ACTH Immunoradiometric (IRMA) Coated Tube2014-05-21
SCANTIBODIES LABORATORY, INC. [Scantibodies Laboratory Inc.]
Duo PTH Immunoradiometric Kit2014-05-21
SCANTIBODIES LABORATORY, INC. [Scantibodies Laboratory Inc.]
Duo PTH Immunoradiometric Kit2014-05-21
SCANTIBODIES LABORATORY, INC. [Scantibodies Laboratory Inc.]
Duo PTH Immunoradiometric Kit2014-05-21
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue Influenza2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
Serum hCG Control Set2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue+ Strep A2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue Chlamydia2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue In-Line Strep A Control Swabs2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
hCG Control Set2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
Strep A Liquid Control Set2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue+ Infectious Mononucleosis2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
Sofia hCG FIA2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
Sofia RSV FIA2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
Sofia Strep A FIA2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
Sofia Strep A FIA2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
Sofia Influenza A+B FIA2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
Sofia Analyzer2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
Sofia Influenza A+B FIA2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
Sofia Analyzer2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
RapidVue hCG2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue RSV2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue RSV2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue One-Step hCG Combo2014-04-17
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue H. pylori gll2014-04-16
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue+ One Step hCG Combo2014-04-16
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue In-Line Strep A2014-04-16
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue Influenza A+B (25T)2014-04-16
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue iFOB2014-04-16
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue One Step hCG Urine2014-04-16
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
QuickVue Dipstick Strep A2014-04-16
LABORATORIOS SCANTIBODIES S.A. DE C.V. [Scantibodies Laboratory Inc.]
Kit, Test, Pregnancy, HCG, Over The Counter2008-01-25
SCANTIBODIES LABORATORY, INC. [Scantibodies Laboratory Inc.]
SYSCON2007-12-31
SCANTIBODIES LABORATORY, INC. [Scantibodies Laboratory Inc.]
Scantibodies Laboratory PTH IRMA Ki2007-12-31
SCANTIBODIES LABORATORY, INC. [Scantibodies Laboratory Inc.]
Calcitonin Immunoradiometric Assay2007-12-31
SCANTIBODIES LABORATORY, INC.
CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)2006-08-30
SCANTIBODIES LABORATORY, INC.
MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG0022006-03-01
SCANTIBODIES LABORATORY, INC.
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT2006-02-27
SCANTIBODIES LABORATORY, INC. [Scantibodies Laboratory Inc.]
ACTH IMMUNORADIOMETRIC(I2006-01-24
SCANTIBODIES LABORATORY, INC.
TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG0132005-10-18
SCANTIBODIES LABORATORY, INC.
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG0142005-09-09
SCANTIBODIES LABORATORY, INC.
TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT2005-07-26
SCANTIBODIES LABORATORY, INC.
WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG0022005-07-26
SCANTIBODIES LABORATORY, INC.
ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG0112005-05-20
SCANTIBODIES LABORATORY, INC.
CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG0012003-07-30
SCANTIBODIES LABORATORY, INC.
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG1002002-06-03
SCANTIBODIES LABORATORY, INC.
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG6002001-04-30
SCANTIBODIES LABORATORY, INC.
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG0562000-08-21
SCANTIBODIES LABORATORY, INC.
SYSCOS IDC - G, IDC, BSC, IDC - G1997-12-24
SCANTIBODIES LABORATORY, INC.
SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY)1996-10-08
SCANTIBODIES LABORATORY, INC.
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)1996-05-06
SCANTIBODIES LABORATORY, INC.
SYSCON TURMOR MARKER CONTROL1996-03-12
SCANTIBODIES LABORATORY, INC.
SYSCON CONTROL ASSAYED & UNASSAYED1996-02-14
SCANTIBODIES LABORATORY, INC.
INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY)1995-07-19
SCANTIBODIES LABORATORY, INC.
COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI1995-07-12

Related Finance Registrations
NCAGE Code5KAW9SCANTIBODIES LABORATORY, INC.
CAGE Code5KAW9SCANTIBODIES LABORATORY, INC.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202009151600Barcelona ,Spain -> Long Beach, CaliforniaPLASTIC MIXING TUB6000 PCS
202009122439Barcelona ,Spain -> Long Beach, CaliforniaPLASTIC MIXING TUB6000 PCS
202009052503Barcelona ,Spain -> Long Beach, CaliforniaPLASTIC MIXING TUB6000 PCS
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