UDI device identifier

First Response™ Ovulation Test 00022600900542

UDI device identifier 00022600900542 · CHURCH & DWIGHT CO., INC.

Key facts

Primary DI 00022600900542
Brand name First Response™ Ovulation Test
Version or model 00022600900542
Company CHURCH & DWIGHT CO., INC.
DUNS number 001211952
Product code CEP
GMDN term Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Premarket submission K973310
Device class Class I
Single use Yes
Packaged sterile No
Implantable No
Publish date Mar 14, 2019
Version date Jun 10, 2022

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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