Asuragen Inc

FDA Filings

This page includes the latest FDA filings for Asuragen 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: 3003436513
• FEI Number: 3003436513
• Name: ASURAGEN, INC.
• Owner & Operator: ASURAGEN, INC.
• Contact Address: 2150 WOODWARD ST. Suite 100 --; Austin TX 78744 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2150 WOODWARD ST Suite 100; AUSTIN, TX 78744 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00850017493087 ASURAGEN, INC.	ROX 1000 Size Ladder A00058	2023-11-16
GUDID 00863840000254 ASURAGEN, INC.	AmplideX Fragile X Dx & Carrier Screen Kit 49591	2020-04-15
PMN DEN190023 | OYV ASURAGEN, INC.	AmplideX Fragile X Dx & Carrier Screen Test	2020-04-02
De Novo DEN190023 Asuragen, Inc.	AmplideX Fragile X Dx & Carrier Screen Kit	2020-02-21
GUDID 00863840000285 ASURAGEN, INC.	RNARetain 84001	2019-11-13
GUDID 00863840000223 ASURAGEN, INC.	QuantideX qPCR BCR-ABL IS Kit 49574	2019-10-18
PZM ASURAGEN, INC.	QuantideX NGS Hotspot 21 Kit	2018-07-26
PMN DEN160003 | OYX ASURAGEN, INC.	QuantideX? qPCR BCR-ABL IS Kit	2016-08-12
De Novo DEN160003 ASURAGEN, INC.	Quantidex QPCR BCR-ABL IS Kit	2016-07-22
PMN K113420 | OZF ASURAGEN, INC.	RNARetain	2012-06-11
OZF ASURAGEN, INC.	RNARetain	2012-06-11
PMN K113420 ASURAGEN, INC.	RNARETAIN	2012-03-16
OYX ASURAGEN, INC.	QuantideX? qPCR BCR-ABL minor Kit	2012-02-02
OYV ASURAGEN, INC.	AmplideX PCR/CE FMR1 Kit	2012-01-25
OYV ASURAGEN, INC.	AmplideX DM-1 Dx Kit	2012-01-25
PPM ASURAGEN, INC.	ROX 1000 Size Ladder	2005-01-03
PPM ASURAGEN, INC.	GC-Rich PCR Reagents	2005-01-03
MVU ASURAGEN, INC.	FMR1 F,R FAM-Primers	2005-01-03
MVU ASURAGEN, INC.	FMR1 CGG Forward Primer	2005-01-03

Related Finance Registrations

NCAGE Code	4GGP6	ASURAGEN, INC.
CAGE Code	4GGP6	ASURAGEN, INC.
S.A.M. Registration	4GGP6 [622988330]	ASURAGEN, INC.
DUNS	622988330	ASURAGEN, INC.
SEC	0001358480	ASURAGEN INC of DELAWARE