Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018771894

FEI Number

3018771894

Entity Name

Q-LINE BIOTECH LIMITED

City/State/Country

Lucknow Uttar Pradesh, IN

Establishment Address

298-281, Transport Nagar, Kanpur Road, Adjacent Transport Nagar Metro Station, Lucknow Uttar Pradesh 226012, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Q-Line Biotech Limited (Owner Number: 10080928)

Owner / Operator Contact Address

298-281, Transport Nagar, Kanpur Road, Adjacent Transport Nagar Metro Station, Lucknow, IN-UP 226012, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Electrodes for Innolyte ISE electrolyte analyser FAMT-2020A Weswox Optik Fully Automatic Rotary Microtome QIA-1100 Immunofluorescence Analyzr to measure cardiac markers, Inflammation markers, Infectious markers, vitamins, etc. VATP-1090A Weswox Optik Automatic Vacuum Tissue Processor Q-Line Uriscan Strips Innolab 200 Semi-Automated Chemistry Analyzer Perdure ICU 09 Innolyte ISE electrolyte analyser for Na, K, Cl Selectra ProM, Astira CX600, Astira CX400, Astira C-MS Automated Chemistry Analyzers Q-Line ALT/GPT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJP	Electrode, Ion Selective (Non-Specified)	Clinical Chemistry	Class 1	862.2050	2021-03-30
IDO	Microtome, Rotary	Pathology	Class 1	864.3010	2022-03-29
JZT	Fluorometer	Immunology	Class 1	866.4520	2022-03-24
IEO	Processor, Tissue, Automated	Pathology	Class 1	864.3875	2022-03-29
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2025-08-09
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2021-03-13
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2022-11-21
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Clinical Chemistry	Class 1	862.2150	2021-03-13
JJG	Analyzer, Chemistry, Centrifugal, For Clinical Use	Clinical Chemistry	Class 1	862.2140	2021-12-24
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2021-03-30

Official Correspondent

Saurabh Garg

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Q-Line Biotech Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21
K760211	Instrumentation Laboratory CO	ANALYZER, GLUCOSE/UREA/CREATININE	1976-08-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2012	Richard-Allan Scientific Company	1	Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018771894. Last updated year: 2026. Please use registration number 3018771894 when referencing this establishment in official correspondence.