Invivoscribe, Inc.

FDA Device Registration & Listing · San Diego, CA, US · Registration 3014173060

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
3014173060
FEI Number
3014173060
Entity Name
Invivoscribe, Inc.
City/State/Country
San Diego, CA, US
Establishment Address
10222 Barnes Canyon Road, Building 1, San Diego, CA 92121, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Invivoscribe, Inc. (Owner Number: 10023809)
Owner / Operator Contact Address
10222 Barnes Canyon Rd., Bldg 1, San Diego, CA 92121, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Invivoscribe Branded RNA and DNA for Oncology Test Development LeukoStrat CDx FLT3 Mutation Assay

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PPM General Purpose Reagent Pathology Class 1 864.4010 2020-10-22
OWD Somatic Gene Mutation Detection System Unknown Class 3 N/A 2017-11-17
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2008-07-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Invivoscribe, 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 3014173060. Last updated year: 2026. Please use registration number 3014173060 when referencing this establishment in official correspondence.
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