FDA Registration
Active
🇮🇳 India
Q-LINE BIOTECH LIMITED
Reg #: 3018771894
·
FEI: 3018771894
·
Expires 2026
Products
13
Proprietary Names
13
Establishment Types
3
Classifications
13
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Registration Details
- Registration Name
- Q-LINE BIOTECH LIMITED
- Registration Number
- 3018771894
- FEI Number
- 3018771894
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 298-281, Transport Nagar, Kanpur Road, Adjacent Transport Nagar Metro Station
- City
- Lucknow Uttar Pradesh
- Country
- IN
Owner / Operator
- Firm Name
- Q-Line Biotech Limited
- Operator Number
- 10080928
- Address
- 298-281, Transport Nagar, Kanpur Road, Adjacent Transport Nagar Metro Station
- City
- Lucknow
- State
- Uttar Pradesh
- Postal Code
- 226012
- Country
- IN
- Correspondent
- Saurabh Garg
US Agent
- Business Name
- FDAbasics
- Contact Name
- Emily Matorin
- Address
- 1 Prospect Park W Apt 4d
- City
- Brooklyn
- State
- NY
- ZIP
- 11215
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Selective (Non-Specified) | JJP | Class 1 | Clinical Chemistry | No | 2021-03-30 |
| Microtome, Rotary | IDO | Class 1 | Pathology | No | 2022-03-29 |
| Fluorometer | JZT | Class 1 | Immunology | No | 2022-03-24 |
| Processor, Tissue, Automated | IEO | Class 1 | Pathology | No | 2022-03-29 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2025-08-09 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2021-03-13 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2022-11-21 |
| Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | JJC | Class 1 | Clinical Chemistry | No | 2021-03-13 |
| Analyzer, Chemistry, Centrifugal, For Clinical Use | JJG | Class 1 | Clinical Chemistry | No | 2021-12-24 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2021-03-30 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2021-03-19 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2023-03-21 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2021-03-30 |
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
Q - Xtra Nucleic Acid Extraction System, Q-line Molecular RNA/DNA Extraction Kit (Magnetic bead / Spin Column)
Q-lisa QL-4800 ELISA Washer
Q-Line AST/GOT
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device