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Macro & Micro-Test HCG Pregnancy Test Midstream

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
Macro & Micro-Test HCG Pregnancy Test Midstream FDA UDI
Generic Name
Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing FDA UDI
Model / Reference
1 test/kit FDA UDI

Identifiers

Primary DI / UDI-DI
06974849369304 FDA UDI
510(k) Number
K230741 FDA UDI
FDA Product Code
LCX FDA UDI
GMDN Term
Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1155 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

Yes

FDA UDI

Convenience Kit

Yes

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

Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing

Macro & Micro-Test HCG Pregnancy Test Midstream by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing.

Cleared under the same submission

K230741 also covers:

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 c634c837-3ce7-422e-b912-d01141c4e10c 33 fields · synced May 30, 2026