Techno Path Manufacturing L T D

FDA Filings

This page includes the latest FDA filings for Techno Path Manufacturing L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008156187
• FEI Number: 3008156187
• Name: Monika Kathmeyer
• Owner & Operator: Techno-path Manufacturing Ltd.
• Contact Address: Fort Henry Business Park ; Ballina IE-TA Tipperary V94TR9X IE
• US Agent:
  • Monika Kathmeyer
  • Technopath Clinical Diagnostics USA
  • 516 3622104
  • monika.kathmeyer@technopathusa.com
• Importing Logistics Registration:
  • Importer: Northwell Core laboratories
  • Address: 10 Nevada Drive Lake Success. ; Lake Success, NY 11042 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: Northwell Core Laboratory
  • Address: 10 Nevada Drive Lake Success. ; Lake Success, NY 11042 UNITED STATES
  • Importer Type: END USER
• Importing Logistics Registration:
  • Importer: VA Medical Center 662
  • Address: 4150 Clement Street San Francisco ; San Francisco, CA 94121 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 99 Lafayette Drive Suite 179; Syosset, NY 11791 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3014240095
• FEI Number: 3014240095
• Name: Technopath Northwell Clinical Diagnostics
• Owner & Operator: Techno-path Manufacturing Ltd.
• Contact Address: Fort Henry Business Park ; Ballina IE-TA Tipperary V94TR9X IE
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 99 Lafayette Drive; Ste. 179 ; Syosset, NY 11791 US

FDA Filings

Device Company	Device	Date
GUDID 05391523442169 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Pus IA323A	2024-11-13
GUDID 05391523442152 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Pus IA322A	2024-11-13
GUDID 05391523442145 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Pus IA321A	2024-11-13
GUDID 05391523442503 TECHNO-PATH MANUFACTURING LIMITED	Multichem SP	2024-03-20
GUDID 05391523442497 TECHNO-PATH MANUFACTURING LIMITED	Multichem SP	2024-03-20
GUDID 05391523440882 TECHNO-PATH MANUFACTURING LIMITED	Multichem A1c HB002T	2022-10-20
GUDID 05391523440875 TECHNO-PATH MANUFACTURING LIMITED	Multichem A1c HB001T	2022-10-20
GUDID 05391523440868 TECHNO-PATH MANUFACTURING LIMITED	Multichem A1c HB000T	2022-10-20
GUDID 05391523440400 TECHNO-PATH MANUFACTURING LIMITED	Multichem U	2022-10-20
GUDID 05391523442312 TECHNO-PATH MANUFACTURING LIMITED	Multichem ID-B	2022-10-18
GUDID 05391523441933 TECHNO-PATH MANUFACTURING LIMITED	Multichem ID-B	2022-09-28
GUDID 05391523441926 TECHNO-PATH MANUFACTURING LIMITED	Multichem ID-SeroNeg	2022-09-28
GUDID 05391523441919 TECHNO-PATH MANUFACTURING LIMITED	Multichem ID-SeroNeg	2022-09-28
GUDID 05391523441902 TECHNO-PATH MANUFACTURING LIMITED	Multichem ID-B	2022-09-28
GUDID 05391523441759 TECHNO-PATH MANUFACTURING LIMITED	Multichem ID-COVID19	2022-09-28
GUDID 05391523441735 TECHNO-PATH MANUFACTURING LIMITED	Multichem ID-COVID19	2022-09-28
GUDID 05391523441728 TECHNO-PATH MANUFACTURING LIMITED	Multichem ID-COVID19	2022-09-28
GUDID 05391523441711 TECHNO-PATH MANUFACTURING LIMITED	Multichem ID-COVID19	2022-09-28
GUDID 05391523441704 TECHNO-PATH MANUFACTURING LIMITED	Multichem ID-COVID19	2022-09-28
GUDID 05391523441681 TECHNO-PATH MANUFACTURING LIMITED	Multichem ID-COVID19	2022-09-28
GUDID 05391523440639 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440622 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440615 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440608 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440592 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440585 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440578 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440561 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440554 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440547 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440530 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440523 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440066 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440059 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440042 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440035 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440028 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523440011 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-28
GUDID 05391523441995 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-27
GUDID 05391523441988 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus IA318X	2022-09-27
GUDID 05391523441971 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus IA317X	2022-09-27
GUDID 05391523441964 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus IA316X	2022-09-27
GUDID 05391523441957 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus IA315MX	2022-09-27
GUDID 05391523441940 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus IA315X	2022-09-27
GUDID 05391523441810 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-27
GUDID 05391523441773 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-27
GUDID 05391523441612 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus	2022-09-27
GUDID 05391523441384 TECHNO-PATH MANUFACTURING LIMITED	Multichem AMH AM503A	2022-09-27
GUDID 05391523441377 TECHNO-PATH MANUFACTURING LIMITED	Multichem AMH AM502A	2022-09-27
GUDID 05391523441360 TECHNO-PATH MANUFACTURING LIMITED	Multichem AMH AM501A	2022-09-27
GUDID 05391523441353 TECHNO-PATH MANUFACTURING LIMITED	Multichem AMH AM503X	2022-09-27
GUDID 05391523441346 TECHNO-PATH MANUFACTURING LIMITED	Multichem AMH AM502X	2022-09-27
GUDID 05391523441339 TECHNO-PATH MANUFACTURING LIMITED	Multichem AMH AM501X	2022-09-27
GUDID 05391523441322 TECHNO-PATH MANUFACTURING LIMITED	Multichem AMH AM500MA	2022-09-27
GUDID 05391523441315 TECHNO-PATH MANUFACTURING LIMITED	Multichem AMH AM500MX	2022-09-27
GUDID 05391523441209 TECHNO-PATH MANUFACTURING LIMITED	Multichem AMH AM500X	2022-09-27
GUDID 05391523441193 TECHNO-PATH MANUFACTURING LIMITED	Multichem AMH AM500A	2022-09-27
GUDID 05391523440936 TECHNO-PATH MANUFACTURING LIMITED	Multichem CSF CF101A	2022-09-27
GUDID 05391523440929 TECHNO-PATH MANUFACTURING LIMITED	Multichem CSF CF100A	2022-09-27
GUDID 05391523440912 TECHNO-PATH MANUFACTURING LIMITED	Multichem CSF CF100X	2022-09-27
GUDID 05391523440905 TECHNO-PATH MANUFACTURING LIMITED	Multichem CSF CF102X	2022-09-27
GUDID 05391523440899 TECHNO-PATH MANUFACTURING LIMITED	Multichem CSF CF101X	2022-09-27
GUDID 05391523440820 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-27
GUDID 05391523440813 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-27
GUDID 05391523440806 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-27
GUDID 05391523440790 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-27
GUDID 05391523440783 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-27
GUDID 05391523440776 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-27
GUDID 05391523440745 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus	2022-09-27
GUDID 05391523440738 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA IA300A	2022-09-27
GUDID 05391523440721 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA IA303X	2022-09-27
GUDID 05391523440714 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA IA302X	2022-09-27
GUDID 05391523440707 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA IA301X	2022-09-27
GUDID 05391523440691 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA IA300X	2022-09-27
GUDID 05391523440677 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-27
GUDID 05391523440660 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-27
GUDID 05391523440653 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-27
GUDID 05391523440646 TECHNO-PATH MANUFACTURING LIMITED	Multichem S Plus	2022-09-27
GUDID 05391523440516 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus IA313A	2022-09-27
GUDID 05391523440509 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus IA312A	2022-09-27
GUDID 05391523440493 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus IA311A	2022-09-27
GUDID 05391523440486 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus IA310A	2022-09-27
GUDID 05391523440479 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus IA313X	2022-09-27
GUDID 05391523440462 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus IA312X	2022-09-27
GUDID 05391523440455 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus IA311X	2022-09-27
GUDID 05391523440448 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus IA314X	2022-09-27
GUDID 05391523440431 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus IA310X	2022-09-27
GUDID 05391523440370 TECHNO-PATH MANUFACTURING LIMITED	Multichem S CH103X	2022-09-27
GUDID 05391523440363 TECHNO-PATH MANUFACTURING LIMITED	Multichem S CH102X	2022-09-27
GUDID 05391523440356 TECHNO-PATH MANUFACTURING LIMITED	Multichem S CH101X	2022-09-27
GUDID 05391523440349 TECHNO-PATH MANUFACTURING LIMITED	Multichem S CH103A	2022-09-27
GUDID 05391523440332 TECHNO-PATH MANUFACTURING LIMITED	Multichem S CH102A	2022-09-27
GUDID 05391523440325 TECHNO-PATH MANUFACTURING LIMITED	Multichem S CH101A	2022-09-27
GUDID 05391523440318 TECHNO-PATH MANUFACTURING LIMITED	Multichem S CH103A.05	2022-09-27
GUDID 05391523440301 TECHNO-PATH MANUFACTURING LIMITED	Multichem S CH102A.05	2022-09-27
GUDID 05391523440295 TECHNO-PATH MANUFACTURING LIMITED	Multichem S CH101A.05	2022-09-27
GUDID 05391523440288 TECHNO-PATH MANUFACTURING LIMITED	Multichem S CH103X.05	2022-09-27
GUDID 05391523440271 TECHNO-PATH MANUFACTURING LIMITED	Multichem S CH102X.05	2022-09-27
GUDID 05391523440264 TECHNO-PATH MANUFACTURING LIMITED	Multichem S CH101X.05	2022-09-27
GUDID 05391523440004 TECHNO-PATH MANUFACTURING LIMITED	Multichem IA Plus 05P76-10	2022-09-27
PMN K162530 | JJY Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem IA Plus (IA300A, 05P76-10, IA310A, IA311A, IA312A, IA313A)	2017-04-03
PMN K162530 | JJY Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem IA Plus (08P86-10)	2017-04-03
PMN K162514 | JJX Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem A1c HB000A, HB001A, HB002A, HB000M, HB000T, HB001T, HB002T	2016-10-27
PMN K162514 | JJX Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem A1c 04V0610	2016-10-27
PMN K132751 | JJY Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem S Plus CH100PLA, CH101PLA, CH102PLA, CH103PLA, CH110PLA.05, CH111PLA.05, CH112PLA.05, CH113PLA	2013-11-04
PMN K132751 | JJY Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem S Plus 05P78-10/11/12	2013-11-04
PMN K132174 | DIF Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem WBT, 04S16-10	2013-11-04
PMN K132174 | DIF Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem WBT WB000A	2013-11-04
PMN K132091 | JJY Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem IA Plus, IA310A, IA311A, IA312A, IA313A,	2013-11-04
PMN K132091 | JJY Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem IA Plus 05P76-10	2013-11-04
PMN K131993 | JJY Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem U, 05P80-10	2013-11-04
PMN K131993 | JJY Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem U UC201A.10 UC202A.10	2013-11-04
PMN K131992 | JJY Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem P, SP41PA,	2013-11-04
PMN K131992 | JJY Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem P 05P81	2013-11-04
PMN K132751 TECHNO-PATH MANUFACTURING LTD.	MULTICHEM S PLUS / S PLUS (ASSAYED)	2013-10-22
PMN K131993 TECHNO-PATH MANUFACTURING LTD.	MULTICHEM U	2013-10-15
PMN K131992 TECHNO-PATH MANUFACTURING LTD.	MULTICHEM P	2013-09-25
PMN K132174 TECHNO-PATH MANUFACTURING LTD.	MULTICHEM WBT	2013-09-20
PMN K132091 TECHNO-PATH MANUFACTURING LTD.	MULTICHEM IA AND IA PLUS	2013-09-20
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem hsTn Unassayed HS301X/MX Assayed HS301A/MA	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem hsTn Assayed 04W26-10	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem WBT Unassayed WB000X	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem U Unassayed - UC201X, UC20BX, UC202X Assayed - UC201A.10, UC202A.10	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem U Assayed Alinity 08P89-10	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem S Unassayed CH101x/102X/103X/101X.05/102X.05/103X.05	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem S Plus Unassayed CH100/101/102/103CRP, CH/110/111/112/113/CRP.05 CH110MCRP.05, CH100MCRP	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem S Plus Unassayed Architect 05P79-10/11/12	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem S Plus Unassayed Alinity 08P87-10/11/12	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem S Plus Assayed CH100/101/102/103PLA CH110/111/112/113PLA.05	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem S Plus Assayed Alinity 08P88-10/11/12	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem S Assayed CH101/102/103A & CH101/102/102A.05	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem P Unassayed SP40PX	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem P Assayed Alinity 08P90-10	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem NB Unassayed NB800X Assayed NB800A	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem ID-SeroNeg SR100N & SR100MN	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem ID-B SR101B & SR101MB	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem IA Unassayed IA300X, IA301X, IA302X, IA303X Assayed IA301A, IA302A, IA303A	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem IA Speciality Unassayed BP300X, BP301X, BP302X, BP303X, BP300MX, Assayed BP300A/BP301A/BP302A/BP303A	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem IA Plus Unassayed - IA310X, IA314X, IA311X, IA312X, IA313X IA310MX	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem D-Dimer Unassayed DM900X, DM900MX, DM901X, DM902X	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem D-Dimer Assayed DM900A, DM900MA, DM901A, DM902A	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem CSF Unassayed CF100X, CF101X, CF102X, Multichem CSF Assayed CF100A, CF101A, CF102A	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem AMH Unassayed AM500X/AM500MX	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem AMH Assayed AM500A/AM500MA	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem AE Unassayed Bilevel -AE600X, AE601X, AE602X, Trilevel - AE610X, AE611X, AE612X,AE613X	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem AE Trilevel Assayed AE610A, AE611A, AE612A, AE613A	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	Multichem AE Assayed Bi Level AE600A, AE601A, AE602A	2009-12-02
OHQ Monika Kathmeyer [Techno-path Manufacturing Ltd.]	MultiCHECK Cardiac Assayed 944-513/514/515	2009-12-02