UDI device identifier

First Response™ Pregnancy Early Result 00022600001317

UDI device identifier 00022600001317 · CHURCH & DWIGHT CO., INC.

Key facts

Primary DI 00022600001317
Brand name First Response™ Pregnancy Early Result
Version or model 00022600001317
Company CHURCH & DWIGHT CO., INC.
DUNS number 001211952
Product code LCX
GMDN term Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Premarket submission K123436
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Jan 31, 2023
Version date Jul 6, 2023
Description Pregnancy Kit

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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