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

FDA UDI

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
50 tests/kit FDA UDI

Identifiers

Primary DI / UDI-DI
06974849369199 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 — FDA UDI — listed in…

Similar devices

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

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 e1b26214-a0dc-46fa-b793-7046492746f4 32 fields · synced May 30, 2026