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Macro & Micro-Test Fluorescence Immunoassay Analyzer

FDA UDI

Class I (US FDA UDI)

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

Identity

Trade Name
Macro & Micro-Test Fluorescence Immunoassay Analyzer FDA UDI
Generic Name
Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Model / Reference
HWTS-IF1000 FDA UDI

Identifiers

Primary DI / UDI-DI
06974849369380 FDA UDI
FDA Product Code
KHO FDA UDI
GMDN Term
Fluorescent immunoassay analyser IVD, laboratory FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2560 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Fluorescent immunoassay analyser IVD, laboratory

Macro & Micro-Test Fluorescence Immunoassay Analyzer by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Fluorescent immunoassay 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 4694d44f-d357-4e61-ab9d-517f0d63458a 32 fields · synced May 30, 2026