Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016611336

FEI Number

3016611336

Entity Name

LABTURBO BIOTECH, LLC

City/State/Country

Princeton, NJ, US

Establishment Address

12 Roszel Road, B102, Princeton, NJ 08540, US

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

LabTurbo Biotech, LLC (Owner Number: 10082497)

Owner / Operator Contact Address

12 Roszel Rd., Princeton, NJ 08540, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LabTurbo 45 Compact System LabTurbo 24 Compact System LabTurbo 96 Compact System LabTurbo 48 Compact System LabTurbo Reaction (PCR) Setup System LabTurbo DNA Mini Kit LabTurbo DNA AIO kit LabTurbo Viral DNA/RNA Mini Kit LabTurbo Forensic DNA Mini Kit LabTurbo viral DNA/RNA AIO kit LabTurbo Stool DNA/RNA mini 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	2024-06-03
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2024-06-03

Official Correspondent

Yi-Fan Lin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LabTurbo Biotech, LLC

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.

Similar Registrations

Registration Number	Establishment Name	Location
3010160459	Tecan Software Competence Center GmbH	Mainz-Kastel Rhineland-Palatinate, DE
3015376545	IMMCO DIAGNOSTICS, INC.	Williamsville, NY, US
3005268307	D&K Engineering, Inc.	San Diego, CA, US
3016068451	LABTURBO BIOTECH CORPORATION	Taipei, TW
3007118747	EUROIMMUN US INC.	Mountain Lakes, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016611336. Last updated year: 2026. Please use registration number 3016611336 when referencing this establishment in official correspondence.