Theratest Laboratories Inc

FDA Filings

This page includes the latest FDA filings for Theratest Laboratories 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: 1421346
• FEI Number: 1421346
• Name: THERATEST LABORATORIES, INC.
• Owner & Operator: THERATEST LABORATORIES, INC.
• Contact Address: 1120 N DuPage Ave --; Lombard IL 60148 US
• Official Correspondent:
  • MARIUS - TEODORESCU
  • x-630-6276069-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1120 N Du Page Ave ; LOMBARD, IL 60148 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K090753 | NHX THERATEST LABORATORIES, INC.	EL-Anti-CCP/2	2010-12-22
PMN K090753 THERATEST LABORATORIES, INC.	THERATEST EL-ANTI-CCP/2	2010-03-05
PMN K092757 | MSV THERATEST LABORATORIES, INC.	EL-B2GPI Scr	2009-11-18
PMN K092757 | MSV THERATEST LABORATORIES, INC.	EL-B2GPI (IgM, IgG, IgA)	2009-11-18
PMN K090760 | JZO THERATEST LABORATORIES, INC.	EL-Anti-Thyroglobulin	2009-11-18
PMN K090760 | JZO THERATEST LABORATORIES, INC.	EL-Anti-TPO	2009-11-18
PMN K090760 THERATEST LABORATORIES, INC.	THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120	2009-09-03
PMN K973882 | MSV THERATEST LABORATORIES, INC.	EL-B2GPI scr	2008-02-13
PMN K972790 | MSV THERATEST LABORATORIES, INC.	EL-B2GPI	2008-02-13
PMN K962050 | DHR THERATEST LABORATORIES, INC.	EL-RF scr	2008-02-13
PMN K955481 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Jo-1	2008-02-13
PMN K954106 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA scr	2008-02-13
PMN K941398 | DHR THERATEST LABORATORIES, INC.	EL-RF/3 IgM, IgG, IgA	2008-02-13
PMN K933712 | DHR THERATEST LABORATORIES, INC.	EL-RF IgM	2008-02-13
PMN K071692 | MVM THERATEST LABORATORIES, INC.	EL-tTG IgA/IgG	2008-02-13
PMN K071692 | MVM THERATEST LABORATORIES, INC.	EL-Glia IgA/IgG	2008-02-13
PMN K071692 | MST THERATEST LABORATORIES, INC.	EL-tTG IgA/IgG	2008-02-13
PMN K071692 | MST THERATEST LABORATORIES, INC.	EL-Glia IgA/IgG	2008-02-13
PMN K060176 | MID THERATEST LABORATORIES, INC.	EL-aCL screen	2008-02-13
PMN K060176 | MID THERATEST LABORATORIES, INC.	EL-aCL IgM, IgG, IgA	2008-02-13
PMN K051066 | MQA THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-ssDNA	2008-02-13
PMN K051066 | MQA THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-dsDNA	2008-02-13
PMN K051066 | MQA THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Sm	2008-02-13
PMN K051066 | MQA THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Scl-70	2008-02-13
PMN K051066 | MQA THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-SSB	2008-02-13
PMN K051066 | MQA THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-SSA	2008-02-13
PMN K051066 | MQA THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-RNP/Sm	2008-02-13
PMN K051066 | MQA THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Histone	2008-02-13
PMN K051066 | MQA THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/9	2008-02-13
PMN K051066 | MQA THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/8	2008-02-13
PMN K051066 | MQA THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/7	2008-02-13
PMN K051066 | MQA THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/6	2008-02-13
PMN K051066 | LRM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-ssDNA	2008-02-13
PMN K051066 | LRM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-dsDNA	2008-02-13
PMN K051066 | LRM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Sm	2008-02-13
PMN K051066 | LRM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Scl-70	2008-02-13
PMN K051066 | LRM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-SSB	2008-02-13
PMN K051066 | LRM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-SSA	2008-02-13
PMN K051066 | LRM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-RNP/Sm	2008-02-13
PMN K051066 | LRM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Histone	2008-02-13
PMN K051066 | LRM THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/9	2008-02-13
PMN K051066 | LRM THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/8	2008-02-13
PMN K051066 | LRM THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/7	2008-02-13
PMN K051066 | LRM THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/6	2008-02-13
PMN K051066 | LLL THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-ssDNA	2008-02-13
PMN K051066 | LLL THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-dsDNA	2008-02-13
PMN K051066 | LLL THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Sm	2008-02-13
PMN K051066 | LLL THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Scl-70	2008-02-13
PMN K051066 | LLL THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-SSB	2008-02-13
PMN K051066 | LLL THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-SSA	2008-02-13
PMN K051066 | LLL THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-RNP/Sm	2008-02-13
PMN K051066 | LLL THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Histone	2008-02-13
PMN K051066 | LLL THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/9	2008-02-13
PMN K051066 | LLL THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/8	2008-02-13
PMN K051066 | LLL THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/7	2008-02-13
PMN K051066 | LLL THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/6	2008-02-13
PMN K051066 | LKP THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-ssDNA	2008-02-13
PMN K051066 | LKP THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-dsDNA	2008-02-13
PMN K051066 | LKP THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Sm	2008-02-13
PMN K051066 | LKP THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Scl-70	2008-02-13
PMN K051066 | LKP THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-SSB	2008-02-13
PMN K051066 | LKP THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-SSA	2008-02-13
PMN K051066 | LKP THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-RNP/Sm	2008-02-13
PMN K051066 | LKP THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Histone	2008-02-13
PMN K051066 | LKP THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/9	2008-02-13
PMN K051066 | LKP THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/8	2008-02-13
PMN K051066 | LKP THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/7	2008-02-13
PMN K051066 | LKP THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/6	2008-02-13
PMN K051066 | LKO THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-ssDNA	2008-02-13
PMN K051066 | LKO THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-dsDNA	2008-02-13
PMN K051066 | LKO THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Sm	2008-02-13
PMN K051066 | LKO THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Scl-70	2008-02-13
PMN K051066 | LKO THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-SSB	2008-02-13
PMN K051066 | LKO THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-SSA	2008-02-13
PMN K051066 | LKO THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-RNP/Sm	2008-02-13
PMN K051066 | LKO THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Histone	2008-02-13
PMN K051066 | LKO THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/9	2008-02-13
PMN K051066 | LKO THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/8	2008-02-13
PMN K051066 | LKO THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/7	2008-02-13
PMN K051066 | LKO THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/6	2008-02-13
PMN K051066 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-ssDNA	2008-02-13
PMN K051066 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-dsDNA	2008-02-13
PMN K051066 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Sm	2008-02-13
PMN K051066 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Scl-70	2008-02-13
PMN K051066 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-SSB	2008-02-13
PMN K051066 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-SSA	2008-02-13
PMN K051066 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-RNP/Sm	2008-02-13
PMN K051066 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Histone	2008-02-13
PMN K051066 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/9	2008-02-13
PMN K051066 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/8	2008-02-13
PMN K051066 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/7	2008-02-13
PMN K051066 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: ANA/6	2008-02-13
PMN K040291 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Chromatin	2008-02-13
PMN K024151 | MQA THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Ribo P	2008-02-13
PMN K024031 | LJM THERATEST LABORATORIES, INC.	EL-ANA Profiles: anti-Centromere	2008-02-13
PMN K071692 THERATEST LABORATORIES, INC.	THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS	2007-11-05
PMN K061376 | MOB THERATEST LABORATORIES, INC.	EL-ANCA: anti-PR3	2007-02-05
PMN K061376 | MOB THERATEST LABORATORIES, INC.	EL-ANCA: anti-MPO	2007-02-05
PMN K061376 THERATEST LABORATORIES, INC.	EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3	2006-07-20
PMN K060176 THERATEST LABORATORIES, INC.	EL-ACL SCREEN; EL-ACL IGM, IGG, IGA	2006-02-07
PMN K051066 THERATEST LABORATORIES, INC.	THERATEST EL-ANA PROFILES	2005-10-07
PMN K040291 THERATEST LABORATORIES, INC.	EL-ANA PROFILES: ANTI-CHROMATIN	2004-03-11
PMN K024151 THERATEST LABORATORIES, INC.	EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P	2003-02-06
PMN K024031 THERATEST LABORATORIES, INC.	THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE	2003-02-06
DGR THERATEST LABORATORIES, INC.	Hu Serum 100 Blood Bank Donors Set	2001-12-06
PMN K002559 THERATEST LABORATORIES, INC.	EL-ANA PROFILES-2K1	2000-09-12
PMN K982622 THERATEST LABORATORIES, INC.	EL-ANA PROFILES: EL-ENA/5	1998-08-13
PMN K982150 THERATEST LABORATORIES, INC.	EL-ANA PROFILES: EL-ENA/4	1998-08-13
PMN K973882 THERATEST LABORATORIES, INC.	EL-B2GP1SCR	1997-12-05
PMN K972790 THERATEST LABORATORIES, INC.	THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR	1997-12-05
PMN K962050 THERATEST LABORATORIES, INC.	THERATEST EL-RFSCR	1996-12-16
PMN K955481 THERATEST LABORATORIES, INC.	THERATEST KIT (MODIFICATION)	1996-03-06
PMN K954106 THERATEST LABORATORIES, INC.	THERATEST LAB, INC., EL-ANASCR KIT	1995-11-14
PMN K950716 THERATEST LABORATORIES, INC.	THERATEST EL-ANA PROFILES TEST SYSTEM	1995-09-26
PMN K941398 THERATEST LABORATORIES, INC.	EL-RF/3 (IGM-IGG-IGA) KIT	1995-07-28
PMN K933712 THERATEST LABORATORIES, INC.	EL-RF TEST SYSTEM: EL-RF-IGM KIT	1994-01-28
PMN K914454 THERATEST LABORATORIES, INC.	THE THERATEST EL-ANA PROFILES	1992-05-22
PMN K905301 THERATEST LABORATORIES, INC.	THE THERATEST ACA TEST	1991-01-14