Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016068451

FEI Number

3016068451

Entity Name

LABTURBO BIOTECH CORPORATION

City/State/Country

Taipei, TW

Establishment Address

B1 & 3F-1, No.150, Sec. 4, Chengde Rd., Shilin Dist.,, Taipei 111, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LabTurbo Biotech Corporation (Owner Number: 10078596)

Owner / Operator Contact Address

3F-1, No. 150, Sec.4, Chengde Rd.,, Shilin Dist.,, Taipei, TW-TPE 111, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LabTurbo 48 Compact System LabTurbo 24 Compact System LabTurbo 96 Compact System LabTurbo Reaction (PCR) Setup System LabTurbo 45 Compact System LabTurbo AIO 24 SP-qPCR Automation System LabTurbo AIO 48 SP-qPCR Automation System LabTurbo Specimen Collection Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2020-10-28
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2024-06-03
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2021-11-04

Official Correspondent

Tina Tsai

US Agent Details

TINA TSAI Email: ttsai@labturbo.com Phone: (609) 8782889

Related Public Records

Same Entity

LabTurbo Biotech Corporation

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
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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3007118747	EUROIMMUN US INC.	Mountain Lakes, NJ, US
1832216	TECO DIAGNOSTICS	ANAHEIM, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016068451. Last updated year: 2026. Please use registration number 3016068451 when referencing this establishment in official correspondence.