Quest I N T Inc

FDA Filings

This page includes the latest FDA filings for Quest I N T 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: 1061839
• FEI Number: 3000206132
• Name: QUEST INTL., INC.
• Owner & Operator: Quest International, Inc.
• Contact Address: 8127 NW 29th Street --; Doral FL 33122 US
• Official Correspondent:
  • Steve L Andrus
  • x-305-5926991-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 8127 NW 29th Street ; Doral, FL 33122 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
PMN K181514 Quest International, Inc.	SeraQuest HSV Type 2 Specific IgG	2019-06-13
GUDID 00850487007418 QUEST INTERNATIONAL, INC.	SeraQuest Q01-480	2019-02-21
GUDID 00850487007371 QUEST INTERNATIONAL, INC.	SeraQuest Q01-470	2019-02-21
GUDID 00850487007180 QUEST INTERNATIONAL, INC.	ReQuest Q01-470	2019-02-21
GUDID 00850487007173 QUEST INTERNATIONAL, INC.	ReQuest Q01-480	2019-02-21
PMN K162276 | MXJ QUEST INTL., INC. [Quest International, Inc.]	SeraQuest EIA - HSV Type 1 IgG	2018-09-20
PMN K152353 | MYF QUEST INTL., INC. [Quest International, Inc.]	SeraQuest EIA - HSV Type 2 IgG	2018-09-20
GUDID 00850487007654 QUEST INTERNATIONAL, INC.	SeraQuest	2018-03-29
GUDID 00850487007647 QUEST INTERNATIONAL, INC.	ReQuest	2018-03-29
GUDID 00850487007630 QUEST INTERNATIONAL, INC.	SeraQuest 01-330	2018-03-29
GUDID 00850487007623 QUEST INTERNATIONAL, INC.	ReQuest 01-330	2018-03-29
GUDID 00850487007616 QUEST INTERNATIONAL, INC.	SeraQuest Q01-130	2018-03-29
GUDID 00850487007609 QUEST INTERNATIONAL, INC.	SeraQuest Q01-580	2018-03-29
GUDID 00850487007593 QUEST INTERNATIONAL, INC.	SeraQuest Q01-240	2018-03-29
GUDID 00850487007586 QUEST INTERNATIONAL, INC.	SeraQuest Q01-200M	2018-03-29
GUDID 00850487007579 QUEST INTERNATIONAL, INC.	SeraQuest Q01-200	2018-03-29
GUDID 00850487007562 QUEST INTERNATIONAL, INC.	SeraQuest Q01-190M	2018-03-29
GUDID 00850487007555 QUEST INTERNATIONAL, INC.	SeraQuest Q01-420	2018-03-29
GUDID 00850487007548 QUEST INTERNATIONAL, INC.	SeraQuest 01-410	2018-03-29
GUDID 00850487007531 QUEST INTERNATIONAL, INC.	SeraQuest 01550Q-1	2018-03-29
GUDID 00850487007524 QUEST INTERNATIONAL, INC.	SeraQuest Q01-490	2018-03-29
GUDID 00850487007517 QUEST INTERNATIONAL, INC.	SeraQuest	2018-03-29
GUDID 00850487007500 QUEST INTERNATIONAL, INC.	SeraQuest	2018-03-29
GUDID 00850487007494 QUEST INTERNATIONAL, INC.	SeraQuest	2018-03-29
GUDID 00850487007487 QUEST INTERNATIONAL, INC.	SeraQuest Q01-260	2018-03-29
GUDID 00850487007470 QUEST INTERNATIONAL, INC.	SeraQuest Q01-250	2018-03-29
GUDID 00850487007463 QUEST INTERNATIONAL, INC.	SeraQuest Q01-230	2018-03-29
GUDID 00850487007456 QUEST INTERNATIONAL, INC.	SeraQuest 01-270H	2018-03-29
GUDID 00850487007449 QUEST INTERNATIONAL, INC.	SeraQuest Q01-210	2018-03-29
GUDID 00850487007432 QUEST INTERNATIONAL, INC.	SeraQuest 01-280H	2018-03-29
GUDID 00850487007425 QUEST INTERNATIONAL, INC.	SeraQuest Q01-310H	2018-03-29
GUDID 00850487007401 QUEST INTERNATIONAL, INC.	SeraQuest Q01-120	2018-03-29
GUDID 00850487007395 QUEST INTERNATIONAL, INC.	SeraQuest Q01-110	2018-03-29
GUDID 00850487007388 QUEST INTERNATIONAL, INC.	SeraQuest Q01-100	2018-03-29
GUDID 00850487007364 QUEST INTERNATIONAL, INC.	SeraQuest Q01-460	2018-03-29
GUDID 00850487007357 QUEST INTERNATIONAL, INC.	SeraQuest Q01-190	2018-03-29
GUDID 00850487007340 QUEST INTERNATIONAL, INC.	SeraQuest Q01-180	2018-03-29
GUDID 00850487007333 QUEST INTERNATIONAL, INC.	SeraQuest Q01-160	2018-03-29
GUDID 00850487007326 QUEST INTERNATIONAL, INC.	SeraQuest Q01-150	2018-03-29
GUDID 00850487007319 QUEST INTERNATIONAL, INC.	SeraQuest Q01-140	2018-03-29
GUDID 00850487007302 QUEST INTERNATIONAL, INC.	ReQuest Q01-310H	2018-03-29
GUDID 00850487007296 QUEST INTERNATIONAL, INC.	ReQuest 01-280	2018-03-29
GUDID 00850487007289 QUEST INTERNATIONAL, INC.	ReQuest	2018-03-29
GUDID 00850487007272 QUEST INTERNATIONAL, INC.	ReQuest 01-270	2018-03-29
GUDID 00850487007265 QUEST INTERNATIONAL, INC.	ReQuest Q01-230	2018-03-29
GUDID 00850487007258 QUEST INTERNATIONAL, INC.	ReQuest Q01-260	2018-03-29
GUDID 00850487007241 QUEST INTERNATIONAL, INC.	ReQuest 1	2018-03-29
GUDID 00850487007234 QUEST INTERNATIONAL, INC.	ReQuest	2018-03-29
GUDID 00850487007227 QUEST INTERNATIONAL, INC.	ReQuest	2018-03-29
GUDID 00850487007210 QUEST INTERNATIONAL, INC.	ReQuest Q01-140	2018-03-29
GUDID 00850487007203 QUEST INTERNATIONAL, INC.	ReQuest Q01-150	2018-03-29
GUDID 00850487007197 QUEST INTERNATIONAL, INC.	ReQuest Q01-490	2018-03-29
GUDID 00850487007166 QUEST INTERNATIONAL, INC.	ReQuest Q01-460	2018-03-29
GUDID 00850487007159 QUEST INTERNATIONAL, INC.	ReQuest 01550Q-1	2018-03-29
GUDID 00850487007142 QUEST INTERNATIONAL, INC.	ReQuest Q01-160	2018-03-29
GUDID 00850487007135 QUEST INTERNATIONAL, INC.	ReQuest 01-410	2018-03-29
GUDID 00850487007128 QUEST INTERNATIONAL, INC.	ReQuest Q01-420	2018-03-29
GUDID 00850487007111 QUEST INTERNATIONAL, INC.	ReQuest Q01-190	2018-03-29
GUDID 00850487007104 QUEST INTERNATIONAL, INC.	ReQuest Q01-190M	2018-03-29
GUDID 00850487007098 QUEST INTERNATIONAL, INC.	ReQuest Q01-200	2018-03-29
GUDID 00850487007081 QUEST INTERNATIONAL, INC.	ReQuest Q01-200M	2018-03-29
GUDID 00850487007074 QUEST INTERNATIONAL, INC.	ReQuest Q01-100	2018-03-29
GUDID 00850487007067 QUEST INTERNATIONAL, INC.	ReQuest Q01-110	2018-03-29
GUDID 00850487007050 QUEST INTERNATIONAL, INC.	ReQuest Q01-240	2018-03-29
GUDID 00850487007043 QUEST INTERNATIONAL, INC.	ReQuest Q01-580	2018-03-29
GUDID 00850487007036 QUEST INTERNATIONAL, INC.	ReQuest Q01-120	2018-03-29
GUDID 00850487007029 QUEST INTERNATIONAL, INC.	ReQuest Q01-130	2018-03-29
GUDID 00850487007012 QUEST INTERNATIONAL, INC.	ReQuest Q01-180	2018-03-29
GUDID 00850487007005 QUEST INTERNATIONAL, INC.	ReQuest Q01-250	2018-03-29
PMN K162276 QUEST INTERNATIONAL, INC	SeraQuest Herpes Type 1 Specific IgG	2016-10-01
PMN K152353 Quest International, Inc.	SeraQuest HSV Type 2 Specific IgG	2016-05-13
DHB QUEST INTL., INC. [Quest International, Inc.]	EnzyDex Acti-Tip System	2013-01-16
DHB QUEST INTL., INC. [Quest International, Inc.]	Allerg Gns Act-Tip System	2013-01-16
LYR QUEST INTL., INC. [Quest International, Inc.]	Auro-Dex Helicobacter pylori-lateral flow	2013-01-15
LYR QUEST INTL., INC. [Quest International, Inc.]	Auro-Dex Helicobacter pylori-Multi-test Lateral Flow	2013-01-15
LSW QUEST INTL., INC. [Quest International, Inc.]	ImmunDex ssDNA Antibodies Acti-Tip System	2013-01-15
LSW QUEST INTL., INC. [Quest International, Inc.]	ImmunDex dsDNA Antibodies Acti-Tip System	2013-01-15
LLL QUEST INTL., INC. [Quest International, Inc.]	ImmunDex Scl-70 Antibodies Acti-Tip System	2013-01-15
LLL QUEST INTL., INC. [Quest International, Inc.]	ImmunDex SS B Antibodies Acti-Tip System	2013-01-15
LLL QUEST INTL., INC. [Quest International, Inc.]	ImmunDex SS A Antibodies Acti-Tip System	2013-01-15
LLL QUEST INTL., INC. [Quest International, Inc.]	ImmunDex Jo-1 Antibodies Acti-Tip System	2013-01-15
LKP QUEST INTL., INC. [Quest International, Inc.]	Sm Antibodies Acti-Tip System	2013-01-15
LKO QUEST INTL., INC. [Quest International, Inc.]	U1-SnRNP Antibodies Acti-Tip System	2013-01-15
LJM QUEST INTL., INC. [Quest International, Inc.]	ImmunoDex ENA Profile 6 Acti-Tip System	2013-01-15
LJM QUEST INTL., INC. [Quest International, Inc.]	ImmunoDex ENA Profile 4 Acti-Tip System	2013-01-15
LJM QUEST INTL., INC. [Quest International, Inc.]	ImmunoDex ANA/ENA Screen Acti-Tip System	2013-01-15
DGO QUEST INTL., INC. [Quest International, Inc.]	Rapid Ens MS Acti-Tip System; Rapid Ens MP/X Acti-Tip System	2013-01-15
DGO QUEST INTL., INC. [Quest International, Inc.]	Auro Dex Visual Ens Lateral Flow Allergy Screening Test	2013-01-15
DGO QUEST INTL., INC. [Quest International, Inc.]	Auro Dex Visual Ens Combo Top Lateral Flow Allergy Screening Test	2013-01-15
DGO QUEST INTL., INC. [Quest International, Inc.]	Allerg Ens Turbo Acti-Tip System	2013-01-15
DGO QUEST INTL., INC. [Quest International, Inc.]	Allerg Ens IMAC Acti-Tip System	2013-01-15
DGO QUEST INTL., INC. [Quest International, Inc.]	Allerg E Acti-Tip System	2013-01-15
PMN K885269 | DHB QUEST INTL., INC. [Quest International, Inc.]	Dexall	2012-12-19
PMN K875066 | DHB QUEST INTL., INC. [Quest International, Inc.]	Dexall	2012-12-19
PMN K864696 | DHB QUEST INTL., INC. [Quest International, Inc.]	Dexall	2012-12-19
PMN K853607 | DGO QUEST INTL., INC. [Quest International, Inc.]	Dexall	2012-12-19
PMN K091260 | LSE QUEST INTL., INC. [Quest International, Inc.]	Triturus EB EA-D IgG	2011-07-06
PMN K091260 | LSE QUEST INTL., INC. [Quest International, Inc.]	SeraQuest EB EA-D IgG	2011-07-06
PMN K091260 | LSE QUEST INTL., INC. [Quest International, Inc.]	ReQuest EB EA-D IgG	2011-07-06
PMN K980059 | LJY QUEST INTL., INC. [Quest International, Inc.]	Triturus Mumps IgG	2011-07-05
PMN K980059 | LJY QUEST INTL., INC. [Quest International, Inc.]	SeraQuest Mumps IgG	2011-07-05
PMN K091260 QUEST INTL., INC.	SERAQUEST EBV EA-D IGG TEST	2009-06-08
PMN K990977 | LJN QUEST INTL., INC. [Quest International, Inc.]	Triturus EB VCA IgM	2008-09-11
PMN K990977 | LJN QUEST INTL., INC. [Quest International, Inc.]	SeraQuest EB VCA IgM	2008-09-11
PMN K990977 | LJN QUEST INTL., INC. [Quest International, Inc.]	ReQuest EB VCA IgM	2008-09-11
PMN K990410 | LSE QUEST INTL., INC. [Quest International, Inc.]	Triturus EB VCA IgG	2008-09-11
PMN K990410 | LSE QUEST INTL., INC. [Quest International, Inc.]	SeraQuest EB VCA IgG	2008-09-11
PMN K990410 | LSE QUEST INTL., INC. [Quest International, Inc.]	ReQuest EB VCA IgG	2008-09-11
PMN K980811 | LKP QUEST INTL., INC. [Quest International, Inc.]	Triturus Anti-Sm/RNP	2008-09-11
PMN K980811 | LKP QUEST INTL., INC. [Quest International, Inc.]	SeraQuest Anti-Sm/RNP	2008-09-11
PMN K980810 | LJM QUEST INTL., INC. [Quest International, Inc.]	Triturus Anti-SS A	2008-09-11
PMN K980810 | LJM QUEST INTL., INC. [Quest International, Inc.]	SeraQuest Anti-SS A	2008-09-11
PMN K980639 | LLL QUEST INTL., INC. [Quest International, Inc.]	SeraQuest Anti-SS B	2008-09-11
PMN K980540 | LKP QUEST INTL., INC. [Quest International, Inc.]	Triturus Anti-Sm	2008-09-11
PMN K980540 | LKP QUEST INTL., INC. [Quest International, Inc.]	SeraQuest Anti-Sm	2008-09-11
PMN K980391 | LRM QUEST INTL., INC. [Quest International, Inc.]	Triturus Anti-dsDNA	2008-09-11
PMN K980391 | LRM QUEST INTL., INC. [Quest International, Inc.]	SeraQuest Anti-dsDNA	2008-09-11
PMN K972295 | LFY QUEST INTL., INC. [Quest International, Inc.]	SeraQuest VZV IgG	2008-09-11
PMN K972295 | LFY QUEST INTL., INC. [Quest International, Inc.]	ReQuest VZV IgG	2008-09-11
PMN K971672 | LGD QUEST INTL., INC. [Quest International, Inc.]	Triturus Toxoplasma IgM	2008-09-11
PMN K971672 | LGD QUEST INTL., INC. [Quest International, Inc.]	SeraQuest Toxoplasma IgM	2008-09-11
PMN K971672 | LGD QUEST INTL., INC. [Quest International, Inc.]	Request Toxoplasma IgM	2008-09-11
PMN K963282 | LGC QUEST INTL., INC. [Quest International, Inc.]	Triturus HSV IgG	2008-09-11
PMN K963282 | LGC QUEST INTL., INC. [Quest International, Inc.]	SeraQuest HSV IgG	2008-09-11
PMN K960092 | LGD QUEST INTL., INC. [Quest International, Inc.]	Triturus Toxoplasma IgG	2008-09-11
PMN K960092 | LGD QUEST INTL., INC. [Quest International, Inc.]	SeraQuest Toxoplasma IgG	2008-09-11
PMN K960092 | LGD QUEST INTL., INC. [Quest International, Inc.]	ReQuest Toxoplasma IgG	2008-09-11
PMN K954191 | LFZ QUEST INTL., INC. [Quest International, Inc.]	Triturus CMV IgG	2008-09-11
PMN K954191 | LFZ QUEST INTL., INC. [Quest International, Inc.]	SeraQuest CMV IgG	2008-09-11
PMN K954191 | LFZ QUEST INTL., INC. [Quest International, Inc.]	ReQuest CMV IgG	2008-09-11
PMN K033915 | LSE QUEST INTL., INC. [Quest International, Inc.]	SeraQuest EBV VCA IgG	2008-09-11
PMN K033780 | LJN QUEST INTL., INC. [Quest International, Inc.]	SeraQuest EBV VCA IgM	2008-09-11
PMN K003069 | MID QUEST INTL., INC. [Quest International, Inc.]	SeraQuest Anti-Cardiolipin IgG	2008-09-11
PMN K961053 | LFX QUEST INTL., INC. [Quest International, Inc.]	SeraQuest Rubella IgG	2008-09-09
PMN K961053 | LFX QUEST INTL., INC. [Quest International, Inc.]	ReQuest Rubella IgG	2008-09-09
PMN K973508 | LYR QUEST INTL., INC. [Quest International, Inc.]	SERAQUEST H. PYLORI IGG	2007-01-31
PMN K973508 | LYR QUEST INTL., INC. [Quest International, Inc.]	SERAQUEST H. PYLORI IGA	2007-01-31
PMN K050590 | LIP QUEST INTL., INC. [Quest International, Inc.]	Triturus Anti-Syphilis IgG	2007-01-31
PMN K050590 | LIP QUEST INTL., INC. [Quest International, Inc.]	SeraQuest Anti-Syphilis IgG	2007-01-31
PMN K050590 | LIP QUEST INTL., INC. [Quest International, Inc.]	ReQuest Anti-Syphilis IgG	2007-01-31
PMN K023592 | DDC QUEST INTL., INC. [Quest International, Inc.]	SERAQUEST ANTI-TG	2007-01-31
PMN K003794 | LYR QUEST INTL., INC. [Quest International, Inc.]	SERAQUEST H. PYLORI IGG	2007-01-31
PMN K003794 | LYR QUEST INTL., INC. [Quest International, Inc.]	SERAQUEST H. PYLORI IGA	2007-01-31
PMN K033915 QUEST INTL., INC.	MODIFICATION TO SERAQUEST EB VCA IGG	2004-01-16
PMN K033780 QUEST INTL., INC.	MODIFICATION TO SERAQUEST VCA IGM	2004-01-15
PMN K023593 QUEST INTL., INC.	SERAQUEST ANTI-THYROID PEROXIDASE (TPO)	2003-02-06
PMN K023592 QUEST INTL., INC.	SERAQUEST ANTI-THYROGLOBULIN	2003-01-06
PMN K991975 | LSE QUEST INTL., INC. [Quest International, Inc.]	Triturus EB NA IgG	2000-12-14
PMN K991975 | LSE QUEST INTL., INC. [Quest International, Inc.]	SeraQuest EB NA IgG	2000-12-14
PMN K991975 | LSE QUEST INTL., INC. [Quest International, Inc.]	ReQuest EB NA IgG	2000-12-14
LJY QUEST INTL., INC. [Quest International, Inc.]	SERAQUEST MUMPS IGM	2000-12-14
LJB QUEST INTL., INC. [Quest International, Inc.]	Seraquest Measles IgM	2000-12-14
PMN K003069 QUEST INTL., INC.	ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM	2000-11-27
PMN K991975 QUEST INTL., INC.	SERAQUEST EB NA IGG	1999-11-02
PMN K990410 QUEST INTL., INC.	SERAQUEST EB VCA IGG	1999-10-28
PMN K990977 QUEST INTL., INC.	SERAQUEST EB VAC IGM	1999-10-06
PMN K982485 QUEST INTL., INC.	SERAQUEST CMV IGM	1999-01-13
PMN K982281 QUEST INTL., INC.	SERAQUEST RUBELLA IGM	1998-10-16
PMN K980639 QUEST INTL., INC.	SERAQUEST ANTI-SSB	1998-06-15
PMN K980540 QUEST INTL., INC.	SERAQUEST ANTI-SM	1998-06-15
PMN K980811 QUEST INTL., INC.	SERAQUEST ANTI-SM/RNP	1998-05-12
PMN K980810 QUEST INTL., INC.	SERAQUEST ANTI-SSA	1998-05-12
PMN K980391 QUEST INTL., INC.	SERAQUEST ANTI-DSDNA	1998-04-24
PMN K980059 QUEST INTL., INC.	SERAQUEST MUMPS IGG	1998-04-23
PMN K972295 QUEST INTL., INC.	SERAQUEST VZV IGG	1997-11-05
PMN K971672 QUEST INTL., INC.	SERAQUEST TOXOPLASMA IGM	1997-10-21
PMN K963282 QUEST INTL., INC.	SERAQUEST HSV IGG	1997-01-22
PMN K982281 | LFX QUEST INTL., INC. [Quest International, Inc.]	Triturus Rubella IgM	1996-12-10
PMN K982281 | LFX QUEST INTL., INC. [Quest International, Inc.]	SeraQuest Rubella IgM	1996-12-10
PMN K982281 | LFX QUEST INTL., INC. [Quest International, Inc.]	ReQuest Rubella IgM	1996-12-10
PMN K961053 QUEST INTL., INC.	SERAQUEST RUBELLA IGG	1996-09-04
PMN K960092 QUEST INTL., INC.	SERAQUEST TOXOPLASMA IGG	1996-06-17
PMN K982485 | LFZ QUEST INTL., INC. [Quest International, Inc.]	Triturus CMV IgM	1996-04-03
PMN K982485 | LFZ QUEST INTL., INC. [Quest International, Inc.]	SeraQuest CMV IgM	1996-04-03
PMN K982485 | LFZ QUEST INTL., INC. [Quest International, Inc.]	ReQuest CMV IgM	1996-04-03
PMN K954191 QUEST INTL., INC.	SERAQUEST CMV IGG	1996-02-23
PMN K891736 QUEST INTL., INC.	PATIENT EXAMINATION GLOVES (LATEX)	1989-05-25
PMN K890356 QUEST INTL., INC.	LATEX EXAMINATION GLOVES NON-STERILE	1989-04-06

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• Quest Diagnostic Incorporated
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Related Finance Registrations

NCAGE Code	64PQ8	QUEST INTERNATIONAL, INC.
CAGE Code	64PQ8	QUEST INTERNATIONAL, INC.