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 Number3003436513
FEI Number3003436513
NameASURAGEN, INC.
Owner & OperatorASURAGEN, INC.
Contact Address2150 WOODWARD ST. Suite 100 --
Austin TX 78744 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2150 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
DeviceDate
ASURAGEN, INC.
AmplideX Fragile X Dx & Carrier Screen Kit 495912020-04-15
ASURAGEN, INC.
AmplideX Fragile X Dx & Carrier Screen Test2020-04-02
Asuragen, Inc.
AmplideX Fragile X Dx & Carrier Screen Kit2020-02-21
ASURAGEN, INC.
RNARetain 840012019-11-13
ASURAGEN, INC.
QuantideX qPCR BCR-ABL IS Kit 495742019-10-18
ASURAGEN, INC.
QuantideX NGS Hotspot 21 Kit2018-07-26
ASURAGEN, INC.
QuantideX? qPCR BCR-ABL IS Kit2016-08-12
ASURAGEN, INC.
Quantidex QPCR BCR-ABL IS Kit2016-07-22
ASURAGEN, INC.
RNARetain2012-06-11
ASURAGEN, INC.
RNARetain2012-06-11
ASURAGEN, INC.
RNARETAIN2012-03-16
ASURAGEN, INC.
QuantideX? qPCR BCR-ABL minor Kit2012-02-02
ASURAGEN, INC.
AmplideX PCR/CE FMR1 Kit2012-01-25
ASURAGEN, INC.
AmplideX DM-1 Dx Kit2012-01-25
ASURAGEN, INC.
ROX 1000 Size Ladder2005-01-03
ASURAGEN, INC.
GC-Rich PCR Reagents2005-01-03
ASURAGEN, INC.
FMR1 F,R FAM-Primers2005-01-03
ASURAGEN, INC.
FMR1 CGG Forward Primer2005-01-03

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