Napoleon Monce

FDA Filings

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

FDA Registration(s)

• Registration Number: 3009335633
• FEI Number: 3009335633
• Name: Napoleon Monce
• Owner & Operator: DIAsource ImmunoAssays, SA
• Contact Address: Rue du Bosquet, 2 ; Louvain-La-Neuve BE-NOTA 1348 BE
• US Agent:
  • Napoleon Monce
  • Gold Standard Diagnostics
  • 530 7598000
  • 530 7598012
  • nmonce@gsdx.us
• Importing Logistics Registration:
  • Importer: FedEx Trade Networks
  • Address: 3800 Forest Hill-Irene Road ; Hickory Hill, TN 38125 UNITED STATES
  • Importer Type: Broker
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2851 Spafford St ; Davis, CA 95618 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Export Device to the United States But Perform No Other Operation on Device

• Registration Number: 3005395143
• FEI Number: 3005395143
• Name: Napoleon Monce
• Owner & Operator: Bee Robotics Ltd
• Contact Address: Unit 32.33 Cibyn Industrial Estate Caernarfon; Gwynedd GB-WLS Wales LL55 2BD GB
• Official Correspondent:
  • Steve O Jones
  • 044-1286-672744-x
• US Agent:
  • Napoleon Monce
  • Gold Standard Diagnostics
  • 855 2686940
  • JRoth@gsdx.us
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2851 Spafford Street Davis; Davis, CA 95618 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
DFQ Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource ImmunoAssays	2019-01-28
JME Napoleon Monce [DIAsource ImmunoAssays, SA]	EURIA-Glucagon	2018-09-03
CGC Napoleon Monce [DIAsource ImmunoAssays, SA]	EURIA-Gastrin	2018-09-03
JKB Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource 11 DOC RIA Test Kit	2018-03-27
NGA Napoleon Monce [DIAsource ImmunoAssays, SA]	FSH IRMA	2017-08-04
CFT Napoleon Monce [DIAsource ImmunoAssays, SA]	PRL IRMA	2017-08-04
CEP Napoleon Monce [DIAsource ImmunoAssays, SA]	LHsp IRMA	2017-08-04
JNO Napoleon Monce [DIAsource ImmunoAssays, SA]	Trypsin RIA	2016-09-28
CGF Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Estrone RIA Test Kit	2014-08-04
CGF Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Estrone ELISA	2014-08-04
CDP Napoleon Monce [DIAsource ImmunoAssays, SA]	Diasource Total T3 RIA	2014-06-02
PMN K123364 | MRG Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource 25OH Vitamin D Total ELISA Test	2013-07-22
OAM Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource IGF-1 RIA Test Kit	2012-04-02
OAM Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource IGF-1 ELISA Test Kit	2012-04-02
JLX Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource 17-Hydroxyprogesterone RIA Test Kit	2012-04-02
JLS Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Progesterone RIA Test Kit	2012-04-02
JLS Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Progesterone ELISA Test Kit	2012-04-02
JKD Napoleon Monce [DIAsource ImmunoAssays, SA]	DRG Proinsulin - Elisa - 96 Tests	2012-04-02
JKC Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Dehydroepiandrosterone RIA Test Kit	2012-04-02
JKC Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Dehydroepiandrosterone ELISA Test Kit	2012-04-02
CIZ Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Androstenedione RIA Test Kit	2012-04-02
CIZ Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Androstenedione ELISA Test kit	2012-04-02
CHP Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Estradiol RIA Test Kit	2012-04-02
CHP Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Estradiol ELISA Test Kit	2012-04-02
CFP Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Insulin RIA Test Kit	2012-04-02
CFP Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Insulin ELISA Test Kit	2012-04-02
CFP Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource AIA-100 kit	2012-04-02
CFL Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource IGFBP-3 ELISA test kit	2011-08-30
CFL Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Human Growth Hormone Urine IRMA Test Kit	2011-08-30
CFL Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Human Growth Hormone RIA Test Kit	2011-08-30
CFL Napoleon Monce [DIAsource ImmunoAssays, SA]	DIAsource Human Growth Hormone ELISA Test Kit	2011-08-30
LXG Napoleon Monce [Bee Robotics Ltd]	TrinBlot	2010-09-07
LXG Napoleon Monce [Bee Robotics Ltd]	RoboBlot	2010-09-07
LXG Napoleon Monce [Bee Robotics Ltd]	QuatroProbe	2010-09-07
LXG Napoleon Monce [Bee Robotics Ltd]	GT-Blot 48	2010-09-07
LXG Napoleon Monce [Bee Robotics Ltd]	BeeBlot	2010-09-07
LXG Napoleon Monce [Bee Robotics Ltd]	BabyBee	2010-09-07
LXG Napoleon Monce [Bee Robotics Ltd]	B20	2010-09-07
LXG Napoleon Monce [Bee Robotics Ltd]	AutoRELI 48	2010-09-07
LXG Napoleon Monce [Bee Robotics Ltd]	AutoCAM 48	2010-09-07

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