Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010030414

FEI Number

3010030414

Entity Name

BIOPTIC INC.

City/State/Country

New Taipei, TW

Establishment Address

4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist., New Taipei 23141, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BiOptic Inc. (Owner Number: 10086887)

Owner / Operator Contact Address

4F., No.108-3 & No. 108-4,Minquan Rd., Xindian Dist., New Taipei, TW-NWT 23141, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Qamp mini Thermal cycler LV Module (30/100 sets); 1mm Beads Tube (36/50/250 pcs); 3mm Beads Tube (36/50/250 pcs) Elution Tube (36/50 pcs); EtOH Tube (36/50 pcs); Sample Tube (36/50 pcs); Syringe (36/50 pcs); Tip Set (36/50 pcs) Micro Vial; Sample tray; Buffer tray; Droppers; PCR tubes; 16+3-well Sample Tube; Rotor plate (for 16+3 tube) DNA Cartridges (S1, S2, S3, F3, N1, N3, L1, L2, L3); RNA Cartridges (R1, NR1, LR1); Protein Cartridges (P2); Quantitative Cartridge Kit; Quantitative marker; Alignment Marker; Size Marker; Separation Buffer; Dilution Buffer; Mineral Oil; Power Supply; Air Pump; Purge Station Qsep Series Bio-Fragment Analyzer (Qsep1, Qsep1-Lite, Qsep1-Plus; Qsep100, Qsep100 Advance; Qsep400; Qsep400 SE; Qsep400 Advance; QsepUltra); Proteinase K (1/11/50/100/130 mg); Carrier RNA (12/140/200 ug); Buffer DWX (50/100/200 mL)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUL	Thermocycler, Generic	Clinical Chemistry	Class 1	862.2310	2023-02-16
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2023-02-16
JJN	Apparatus, Electrophoresis, For Clinical Use	Clinical Chemistry	Class 1	862.2485	2022-12-20
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2023-09-11

Official Correspondent

Yutien Huang

US Agent Details

Varoujan Amirkhanian Email: varoujamirkhanian@gmail.com Phone: (818) 6794413

Related Public Records

Same Entity

BiOptic Inc.

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

View Entity Profile →

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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3003673482	Life Technologies Holdings Pte Ltd.	SINGAPORE North West, SG
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010030414. Last updated year: 2026. Please use registration number 3010030414 when referencing this establishment in official correspondence.