Immunostics Inc

FDA Filings

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

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

• BODITECH MED INC.
• Andrea Geffon

FDA Registration(s)

• Registration Number: 2244821
• FEI Number: 2244821
• Name: IMMUNOSTICS, INC.
• Owner & Operator: IMMUNOSTICS, INC.
• Contact Address: 38 INDUSTRIAL WAY EAST, SUITE 1 --; Eatontown NJ 07724 US
• Official Correspondent:
  • ANDREA GEFFON
  • 001-732-9180770-303
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 38 Industrial Way East, Suite 1 ; Eatontown, NJ 07724 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
PQO IMMUNOSTICS, INC.	ALFIS AMH	2019-06-27
MRG IMMUNOSTICS, INC.	ALFIS Vitamin D	2019-06-27
JLW IMMUNOSTICS, INC.	ALFIS TSH	2019-06-27
JLS IMMUNOSTICS, INC.	ALFIS Progesterone	2019-06-27
DHA IMMUNOSTICS, INC.	ALFIS HCG	2019-06-27
CEC IMMUNOSTICS, INC.	ALFIS FT4	2019-06-27
PMN K163554 | KHE IMMUNOSTICS, INC.	hema-screen ER XCEL Enhanced Readability FOBT	2019-01-24
PMN K163465 | GKR IMMUNOSTICS, INC.	hemochroma PLUS Optical System Check	2018-11-27
PMN K163465 | GKR IMMUNOSTICS, INC.	hemochroma PLUS Microcuvettes	2018-11-27
PMN K163465 | GKR IMMUNOSTICS, INC.	hemochroma PLUS Control	2018-11-27
PMN K163465 | GKR IMMUNOSTICS, INC.	hemochroma PLUS Analyzer	2018-11-27
PMN K163465 | GKR IMMUNOSTICS, INC.	hemochroma PLUS Analyzer Promo Kit	2018-11-27
PMN K163465 | GGM IMMUNOSTICS, INC.	hemochroma PLUS Optical System Check	2018-11-27
PMN K163465 | GGM IMMUNOSTICS, INC.	hemochroma PLUS Microcuvettes	2018-11-27
PMN K163465 | GGM IMMUNOSTICS, INC.	hemochroma PLUS Control	2018-11-27
PMN K163465 | GGM IMMUNOSTICS, INC.	hemochroma PLUS Analyzer	2018-11-27
PMN K163465 | GGM IMMUNOSTICS, INC.	hemochroma PLUS Analyzer Promo Kit	2018-11-27
PMN K182298 | GKR IMMUNOSTICS, INC.	hemochroma PLUS Optical System Check	2018-11-19
PMN K182298 | GKR IMMUNOSTICS, INC.	hemochroma PLUS Microcuvettes	2018-11-19
PMN K182298 | GKR IMMUNOSTICS, INC.	hemochroma PLUS Control	2018-11-19
PMN K182298 | GKR IMMUNOSTICS, INC.	hemochroma PLUS Analyzer	2018-11-19
PMN K182298 | GKR IMMUNOSTICS, INC.	hemochroma PLUS Analyzer Promo Kit	2018-11-19
PMN K182298 | GGM IMMUNOSTICS, INC.	hemochroma PLUS Optical System Check	2018-11-19
PMN K182298 | GGM IMMUNOSTICS, INC.	hemochroma PLUS Microcuvettes	2018-11-19
PMN K182298 | GGM IMMUNOSTICS, INC.	hemochroma PLUS Control	2018-11-19
PMN K182298 | GGM IMMUNOSTICS, INC.	hemochroma PLUS Analyzer	2018-11-19
PMN K182298 | GGM IMMUNOSTICS, INC.	hemochroma PLUS Analyzer Promo Kit	2018-11-19
PMN K182298 Immunostics, Inc.	Hemochroma PLUS System	2018-11-16
PMN K171484 | KHE IMMUNOSTICS, INC.	hema-screen Specific Gold	2018-05-25
PMN K163465 IMMUNOSTICS, INC.	Hemochroma PLUS System	2017-09-08
PMN K163225 IMMUNOSTICS, INC.	AFIAS IFOB With AFIAS-50	2017-08-08
PMN K171484 Immunostics, Inc.	Hema-screen SPECIFIC Gold	2017-06-14
PMN K163554 Immunostics, Inc.	Hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test	2017-01-17
PMN K941090 | DHA IMMUNOSTICS, INC.	UniStep HCG Pregnancy Test Strip	2016-11-07
PMN K941090 | DHA IMMUNOSTICS, INC.	UniStep HCG Pregnancy Test Device	2016-11-07
PMN K032992 | LCX IMMUNOSTICS, INC.	UniMark HCG Home Pregnancy Test Device	2016-11-07
PMN K013194 | JHI IMMUNOSTICS, INC.	UniMark Combo Pregnancy Test Strip	2016-11-07
PMN K013194 | JHI IMMUNOSTICS, INC.	UniMark Combo Pregnancy Test Device	2016-11-07
PMN K972456 | DHR IMMUNOSTICS, INC.	Detector Rheumacol	2016-09-20
PMN K926569 | DHR IMMUNOSTICS, INC.	Detector Rheumacol-Lex	2016-09-20
PMN K926569 | DHR IMMUNOSTICS, INC.	Detector Lex-RA	2016-09-20
KHE IMMUNOSTICS, INC.	hema-screen Combi GF	2016-09-20
PMN K894780 | GTQ IMMUNOSTICS, INC.	Detector ASO	2015-12-11
PMN K894780 | GTQ IMMUNOSTICS, INC.	Detector ASO Lexacol	2015-12-11
PMN K861016 | KTN IMMUNOSTICS, INC.	Detector/Color-IM	2015-08-25
OHQ IMMUNOSTICS, INC.	hema-screen SPECIFIC GOLD Hemoglobin Controls	2015-08-25
OHQ IMMUNOSTICS, INC.	hCG Control Kit	2015-08-25
OHQ IMMUNOSTICS, INC.	Detector RPR Control Kit	2015-08-25
GTY IMMUNOSTICS, INC.	Detector Strepacol	2015-08-25
PMN K960174 | LCX IMMUNOSTICS, INC.	UniMark HCG Midstream Pregnancy Test Stick	2015-08-24
PMN K960174 | LCX IMMUNOSTICS, INC.	To Life	2015-08-24
PMN K960174 | LCX IMMUNOSTICS, INC.	Detector hCG Personal	2015-08-24
PMN K960174 | LCX IMMUNOSTICS, INC.	Detector Personal	2015-08-24
PMN K960174 | LCX IMMUNOSTICS, INC.	Am I Pregnant?	2015-08-24
PMN K022755 | KHE IMMUNOSTICS, INC.	Early Discovery	2015-08-24
PMN K102664 IMMUNOSTICS, INC.	HEMA SCREEN ER	2011-01-28
PMN K060463 | KHE IMMUNOSTICS, INC.	hema screen SPECIFIC	2009-09-14
PMN K972606 | JHJ IMMUNOSTICS, INC.	Detector PREGNACOL 2000	2008-04-23
PMN K972457 | KTN IMMUNOSTICS, INC.	Detector/Lex-IM	2008-04-23
PMN K972457 | KTN IMMUNOSTICS, INC.	Detector MONOCOL/LEX	2008-04-23
PMN K902360 | KHE IMMUNOSTICS, INC.	hema-screen	2008-04-23
PMN K853105 | KTN IMMUNOSTICS, INC.	Detector/Monocol	2008-04-23
PMN K842110 | JHJ IMMUNOSTICS, INC.	Detector/cept-d POLYCLONAL	2008-04-23
PMN K834390 | DCN IMMUNOSTICS, INC.	Detector/Lex-CRP	2008-04-23
PMN K041728 | JHI IMMUNOSTICS, INC.	Detector hCG Stick	2008-04-23
PMN K041728 | JHI IMMUNOSTICS, INC.	Detector hCG Combi	2008-04-23
PMN K041728 | JHI IMMUNOSTICS, INC.	DETECTOR HCG	2008-04-23
PMN K060463 IMMUNOSTICS, INC.	HEMA SCREEN SPECIFIC IFOBT	2006-06-06
PMN K041728 IMMUNOSTICS, INC.	HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE	2004-08-11
PMN K031490 IMMUNOSTICS, INC.	RUBELLACOL	2003-07-16
PMN K992759 IMMUNOSTICS, INC.	COLON ALERT TEST	1999-12-06
PMN K972457 IMMUNOSTICS, INC.	MONOCOL/LEX-IM TEST	1997-12-01
PMN K972456 IMMUNOSTICS, INC.	RHEUMACOL RHEUMATOID FACTOR TEST	1997-11-25
PMN K972606 IMMUNOSTICS, INC.	PREGNACOL PREGNANCY TEST	1997-08-29
GSO IMMUNOSTICS, INC.	Immuno Bactacol Febrile Antigens	1992-10-21
GSN IMMUNOSTICS, INC.	Immuno Bactacol Febrile Positive Control	1992-10-21
GSN IMMUNOSTICS, INC.	Immuno Bactacol Febrile Negative Control	1992-10-21
GRL IMMUNOSTICS, INC.	Immuno Bactacol Febrile Antigens	1992-10-21
GNC IMMUNOSTICS, INC.	Immuno Bactacol Febrile Antigens	1992-10-21

Similar & Related FDA Registered Companies

• IMMUNOSTICS CO., INC.

Related Finance Registrations

SEC

0001684904

Immunostics, Inc. of NEW JERSEY

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202006066902	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	SOFT PACKING, PP SHEET	10 CTN
2020050520579	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MICROTOMES PARTS AND ACCESSORIES HS CODE 9027 90	106 CTN
2020030525095	Pusan,South Korea -> Long Beach, California	MICROTOMES PARTS AND ACCESSORIES HS CODE 9027 90	78 CTN
2020020823237	Nhava Sheva,India -> New York/Newark Area, Newark, New Jersey	IFOB PRINTED TISSUE, ENGLISH, SPANISH FOLDED .	100 PKG
202001247109	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	SOFT PACKING, PP SHEET	27 CTN
202001238788	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	SOFT PACKING, PP SHEET	27 CTN
2019123011749	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	PLASTIC BOTTLE	80 CTN
2019082714279	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MICROTOMES PARTS AND ACCESSORIES HS CODE 9027 90	113 CTN