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Easy Amp Real-time Fluorescence Isothermal Detection System

FDA UDI

Class II (US FDA UDI)

by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Identity

Trade Name
Easy Amp Real-time Fluorescence Isothermal Detection System FDA UDI
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Model / Reference
HWTS-1600P FDA UDI

Identifiers

Primary DI / UDI-DI
06974849369083 FDA UDI
FDA Product Code
NSU FDA UDI
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory

Easy Amp Real-time Fluorescence Isothermal Detection System by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Thermal cycler nucleic acid amplification analyser IVD, laboratory.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Sources (1)

  • FDA UDI 92c7b0de-06e7-4051-971d-0bc3348765b1 32 fields · synced May 30, 2026