ASURAGEN, INC.

FDA Device Registration & Listing · AUSTIN, TX, US · Registration 3003436513

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003436513
FEI Number
3003436513
Entity Name
ASURAGEN, INC.
City/State/Country
AUSTIN, TX, US
Establishment Address
2150 WOODWARD ST, Suite 100, AUSTIN, TX 78744, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
ASURAGEN, INC. (Owner Number: 9049048)
Owner / Operator Contact Address
2150 WOODWARD ST. Suite 100, --, Austin, TX 78744, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

AmplideX DM-1 Dx Kit AmplideX PCR/CE FMR1 Kit AmplideX SMA Plus Kit ROX 1000 Size Ladder GC-Rich PCR Reagents AmplideX Fragile X Dx & Carrier Screen Test QuantideX® qPCR BCR-ABL minor Kit QuantideX® qPCR BCR-ABL IS Kit RNARetain

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OYV Inherited Nucleotide Repeat Disorder Dna Test Immunology Class 2 866.5970 2012-01-25
PTA Genetic Variant Detection And Health Risk Assessment System Immunology Class 2 866.5950 2020-07-16
PPM General Purpose Reagent Pathology Class 1 864.4010 2005-01-03
OYV Inherited Nucleotide Repeat Disorder Dna Test Immunology Class 2 866.5970 2020-04-02
OYX Bcr/Abl1 Monitoring Test Medical Genetics Class 2 866.6060 2012-02-02
OZF Tissue Rna Preservative For Collection, Storage, And Transportation Immunology Class 2 866.4070 2012-06-11

Official Correspondent

Stephanie Mantooth

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ASURAGEN, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003436513. Last updated year: 2026. Please use registration number 3003436513 when referencing this establishment in official correspondence.
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