Data / Medical devices / United States / Invivoscribe, Inc.
Invivoscribe, Inc.: FDA-registered device maker in San Diego, CA, United States, 1 PMA approval
Invivoscribe, Inc. is registered with the FDA (registration 3014173060) in San Diego, CA, United States. It lists 3 device types. The FDA files 1 PMA approval under its listings, the newest dated April 28, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014173060
- Address
- 10222 Barnes Canyon Road, Building 1, San Diego, CA, United States, 92121
- Owner or operator
- Invivoscribe, Inc. (10023809)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 21, 2008
- Registered through
- 2027
- Brand names listed
- Invivoscribe Branded RNA and DNA for Oncology Test Development, LeukoStrat CDx FLT3 Mutation Assay
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| General Purpose Reagent | PPM | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Somatic Gene Mutation Detection System | OWD | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 28, 2017 | P160040 | LeukoStrat CDx FLT3 Mutation Assay | OWD | 12 | September 27, 2024 | accessdata.fda.gov |
Compare with other makers
- All makers of Somatic Gene Mutation Detection System
- All makers of General Purpose Reagent
- All makers of Reagents, Specific, Analyte
Updated September 27, 2024. 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.