Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007648367

FEI Number

3007648367

Entity Name

BioGenex Life Sciences Pvt. Ltd.

City/State/Country

Ranga Reddy District Telangana, IN

Establishment Address

Plot No.4, Survey No. 656/A, Aero Space and Precision Engineering Industries SEZ, Adibatla (V), Ibrahimpatnam (M), Ranga Reddy District Telangana 501510, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIOGENEX LABORATORIES INC. (Owner Number: 2936532)

Owner / Operator Contact Address

48810 Kato Road,Suite 100E&200E, --, Fremont, CA 94538, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

I6000 AUTOMATED STAINING SYSTEM i500 Plus EZ-RETRIEVER SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2006-07-18
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2004-07-29

Official Correspondent

No official correspondent registered.

US Agent Details

KRISHAN L Kalra Business: BIOGENEX LABORATORIES INC Email: k.kalra@biogenex.com Phone: (510) 8241400

Related Public Records

Same Entity

BIOGENEX LABORATORIES 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
3008776165	BIOGENEX LABORATORIES INC.	Fremont, CA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007648367. Last updated year: 2026. Please use registration number 3007648367 when referencing this establishment in official correspondence.