Data / Medical devices / United States / Asuragen, Inc.
Asuragen, Inc.: FDA-registered device maker in Austin, TX, United States, 3 510(k) clearances
Asuragen, Inc. is registered with the FDA (registration 3003436513) in Austin, TX, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 21, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003436513
- Address
- 2150 WOODWARD ST Suite 100, Austin, TX, United States, 78744
- Owner or operator
- ASURAGEN, INC. (9049048)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- January 3, 2005
- Registered through
- 2026
- Brand names listed
- AmplideX DM-1 Dx Kit, AmplideX Fragile X Dx & Carrier Screen Test, AmplideX PCR/CE FMR1 Kit, AmplideX SMA Plus Kit, GC-Rich PCR Reagents, QuantideX® qPCR BCR-ABL IS Kit, QuantideX® qPCR BCR-ABL minor Kit, RNARetain and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bcr/Abl1 Monitoring Test | OYX | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Genetic Variant Detection And Health Risk Assessment System | PTA | 2 | Manufacturer for export | accessdata.fda.gov |
| Inherited Nucleotide Repeat Disorder Dna Test | OYV | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Tissue Rna Preservative For Collection, Storage, And Transportation | OZF | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 21, 2020 | DEN190023 | AmplideX Fragile X Dx & Carrier Screen Kit | OYV | Unknown | Asuragen, Inc. | accessdata.fda.gov |
| July 22, 2016 | DEN160003 | Quantidex qPCR BCR-ABL IS Kit | OYX | Unknown | Asuragen, Inc. | accessdata.fda.gov |
| March 16, 2012 | K113420 | RNARETAIN | OZF | Substantially Equivalent | Asuragen, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bcr/Abl1 Monitoring Test
- All makers of Genetic Variant Detection And Health Risk Assessment System
- All makers of General Purpose Reagent
Updated February 21, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.