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Zioxx

FDA UDI

Class II (US FDA UDI)

by Weihai Kangzhou Biotechnology Engineering Co., Ltd

Identity

Trade Name
ZIOXX FDA UDI
Generic Name
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Model / Reference
midstream FDA UDI

Identifiers

Primary DI / UDI-DI
06923304600049 FDA UDI
510(k) Number
K183097 FDA UDI
FDA Product Code
LCX FDA UDI
GMDN Term
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1155 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Zioxx by Weihai Kangzhou Biotechnology Engineering Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K183097 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Weihai Kangzhou Biotechnology Engineering Co., Ltd

Sources (1)

  • FDA UDI 44c3b872-fd2d-4acd-9877-e9f588700af2 34 fields · synced Jun 1, 2026