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Clearblue

FDA UDI

Class II (US FDA UDI)

by Spd Swiss Precision Diagnostics Gmbh

Identity

Trade Name
Clearblue FDA UDI
Generic Name
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Device Name
A convenience kit consisting of 2 Clearblue Digital Pregnancy Test devices and 8 Clearblue Rapid Detection Pregnancy Test devices FDA UDI
Model / Reference
Rapid and Digital Detection Pregnancy Tests FDA UDI
Description
A convenience kit consisting of 2 Clearblue Digital Pregnancy Test devices and 8 Clearblue Rapid Detection Pregnancy Test devices FDA UDI

Identifiers

Primary DI / UDI-DI
00633472602054 FDA UDI
510(k) Number
K060128 FDA UDI
K110433 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

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

No

FDA UDI

Clearblue by Spd Swiss Precision Diagnostics Gmbh — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K060128 also covers:

K110433 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spd Swiss Precision Diagnostics Gmbh

Sources (1)

  • FDA UDI 53bce128-1623-46ee-85d1-e47e0c8641f1 37 fields · synced Jun 8, 2026