NOVASCOPE BIOCHIPS INC.

FDA Device Registration & Listing · Boston, MA, US · Registration 3042585783

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
3042585783
FEI Number
3042585783
Entity Name
NOVASCOPE BIOCHIPS INC.
City/State/Country
Boston, MA, US
Establishment Address
No.38 Wareham St., Boston, MA 02118, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Novascope Biochips Inc. (Owner Number: 10094762)
Owner / Operator Contact Address
No.38 Wareham St., Boston, MA 02118, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Microorganism Identification Biochip Immunohistochemistry Reagents and Kits

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LIB Device, General Purpose, Microbiology, Diagnostic Microbiology Class 1 866.2660 2025-12-22
NJT Immunohistochemistry Reagents And Kits Hematology Class 1 864.1860 2025-12-22

Official Correspondent

Jiunn-Tyng Yeh

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Similar Registrations

Registration Number Establishment Name Location
3009756327 Synergy Health Ede BV Ede Gelderland, NL
3008850249 CHANGZHOU DSB MEDICAL CO., LTD Changzhou City Jiangsu, CN
3014642322 PRECISION CONVERTING SOLUTIONS LTD. Khlong Luang Pathum Thani, TH
8010096 OXOID, LTD. BASINGSTOKE, HAMPSHIRE, GB
1423625 INTL. MEDSURG CONNECTION, INC. Schaumburg, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042585783. Last updated year: 2026. Please use registration number 3042585783 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.