What is FDA product code PHG?

A droplet digital PCR system is an in vitro diagnostic amplification and detection test system that is intended for the amplification, detection (qualitative and quantitative), and analysis of nucleic acid samples, isolated from clinical specimens, which have been partitioned into nanoliter or smaller droplets using a water oil emulsion technique. A droplet digital PCR system is intended for use with cleared or approved in vitro diagnostic assays which specify its use.

Clinical Chemistry › Laboratory InstrumentsDroplet Digital Pcr System

Targetingone

Name: Targetingone
Brand: Targetingone

7 catalogue numbers from Chip Reader/Chip Reader R2, listed by TargetingOne Technology (Beijing) Corporation, under Droplet Digital Pcr System. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

7catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code PHG
Manufacturer	City	Province	Registered as	Device types
Suzhou Sniper Medical Technologies Co., Ltd.	Suzhou	Jiangsu	Manufacturer	4

Record

Regulatory record for Targetingone
Listed by	TargetingOne Technology (Beijing) Corporation
FDA product code	PHG
Device type	Droplet Digital Pcr System
Device class	Class 2
Regulation	21 CFR 862.2570
Premarket notification	Exempt
Record published	2023-10-20
Record revised	2025-07-14 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Targetingone
Catalogue number	Size	Status
Chip Reader/Chip Reader R2		In distribution
Chip Reader/ Chip Reader R1		In distribution
Drop Maker/Drop Maker M1		In distribution
D30 Automatic Digital PCR System /D30		In distribution
Digital PCR analysis System/D2		In distribution
Digital PCR analysis System/D1		In distribution
D50 Automatic Digital PCR System/D50		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
QIAcuityDx® Four	Qiagen, Gmbh	1
QIAcuityDx® Nanoplate 26k 24-well	Qiagen, Gmbh	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.