BIOCHECK, INC.

FDA Device Registration & Listing · Pleasant Hill, CA, US · Registration 2953756

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
2953756
FEI Number
3002564473
Entity Name
BIOCHECK, INC.
City/State/Country
Pleasant Hill, CA, US
Establishment Address
3451 Vincent Rd, Pleasant Hill, CA 94523, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
BIOCHECK, INC. (Owner Number: 9033543)
Owner / Operator Contact Address
3451 Vincent Road, --, Pleasant Hill, CA 94523, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

DxDATA Glial Fibrillary Acidic Protein (GFAP) CLIA Kit, DXDA-1003 DxDATA Protein Gene Product 9.5 (PGP 9.5) CLIA Kit, DXDA-1004

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QAT Brain Trauma Assessment Test Immunology Class 2 866.5830 2024-12-05

Official Correspondent

Johanna Saito

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3002800697 DRG INSTRUMENTS GMBH MARBURG Hesse, DE
2245285 DRG International, Inc. Springfield, NJ, US

Similar Registrations

Registration Number Establishment Name Location
2085064 CLINIQA CORPORATION San Marcos, CA, US
3008344661 ABBOTT IRELAND SLIGO, IE
3005333358 ABBOTT LABORATORIES Lake Forest, IL, US
2032839 EPITOPE DIAGNOSTICS, INC. SAN DIEGO, CA, US
3005643513 ABBOTT POINT OF CARE CANADA LIMITED Ottawa Ontario, CA
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2953756. Last updated year: 2026. Please use registration number 2953756 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.