INANOVATE INC

FDA Device Registration & Listing · Sioux Falls, SD, US · Registration 3042641161

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
3042641161
FEI Number
3042641161
Entity Name
INANOVATE INC
City/State/Country
Sioux Falls, SD, US
Establishment Address
4800 N Career Ave Ste 132, Sioux Falls, SD 57107, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Inanovate Inc (Owner Number: 10094564)
Owner / Operator Contact Address
4800 N. Career Ave. STE 132, Sioux Falls, SD 57107, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K252627
PMA Number
N/A

All Registered Proprietary Names

Lyme-ID IgG Test Bio-ID800

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2025-12-08
NSU Instrumentation For Clinical Multiplex Test Systems Clinical Chemistry Class 2 862.2570 2025-12-08

Official Correspondent

Aaron Harmon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2018 Hologic, Inc 2
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042641161. Last updated year: 2026. Please use registration number 3042641161 when referencing this establishment in official correspondence.
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