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Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)

FDA UDIEUDAMED

Class I (US FDA UDI)

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

Identity

Trade Name
Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold) FDA UDI
Generic Name
Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical FDA UDI
Model / Reference
10 tests/kit FDA UDI

Identifiers

Primary DI / UDI-DI
06974849369182 FDA UDI
FDA Product Code
GOB FDA UDI
GMDN Term
Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical

Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class I — IVDD, FDA UDI…

Similar devices

Also classified as Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

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Manufacturer

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

Sources (2)

  • FDA UDI 80ad15c4-e92a-4b44-a4e4-9a096bd46e9d 32 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026