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 10 Clearblue Easy Ovulation Test device and 1 Clearblue Rapid Dectection Pregnancy Test. FDA UDI
Model / Reference: Easy Ovulation Kit FDA UDI
Description: A convenience kit consisting of 10 Clearblue Easy Ovulation Test device and 1 Clearblue Rapid Dectection Pregnancy Test. FDA UDI

Identifiers

Primary DI / UDI-DI: 00633472601026 FDA UDI
510(k) Number: K110433 FDA UDI
K981271 FDA UDI
FDA Product Code: LCX FDA UDI
CEP 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
862.1485 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Natural conception assistance kit

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

Similar devices

Also classified as Natural conception assistance kit.

Dr. Talbot's — TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS LLC · Class I
Easy@Home Ovulation Test Kit (50 LH strips + 20 HCG strips ) — EASY HEALTHCARE CORPORATION · Class II
Topcare — Topco Associates, LLC · Class I
PREGABLE Ovulation Test Kit — Equinox Biotech Co., Ltd. · Class I
DAVID — Equinox Biotech Co., Ltd. · Class I
Smilereader ovulation test kit — Equinox Biotech Co., Ltd. · Class I
Easy@Home Ovulation Test Strip (50 tests kit) — EASY HEALTHCARE CORPORATION · Class I
Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II

Cleared under the same submission

K110433 also covers:

K981271 also covers:

H.E.B — H. E. BUTT GROCERY COMPANY
Kroger — KROGER CO., THE
Meijer — MEIJER, INC.
Topcare — Topco Associates, LLC
CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Equate — Walmart Stores

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Spd Swiss Precision Diagnostics Gmbh

Sources (1)

FDA UDI 36627971-f9b5-482b-ad7f-743279d642c7 36 fields · synced May 30, 2026