UDI device identifier

Kroger Digital & One Step Pregnancy Test

UDI device identifier 00041260012501 · KROGER CO., THE

Key facts

Primary DI 00041260012501
Brand name Kroger
Version or model Digital & One Step Pregnancy Test
Company KROGER CO., THE
DUNS number 006999528
Product code LCX
GMDN term Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Premarket submission K042280
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Aug 4, 2021
Version date Jan 31, 2024
Description A convenience kit consisting of 1 Digital Pregnancy Test and 1 Early Result Pregnancy Test

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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