UDI device identifier

LEADER 5646930

UDI device identifier 00096295139884 · Cardinal Health 110, Inc.

Key facts

Primary DI 00096295139884
Brand name LEADER
Version or model 5646930
Catalog number 5646930
Company Cardinal Health 110, Inc.
DUNS number 063997360
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 11, 2020
Version date Jul 6, 2023
Description LDR One-step pregnancy Test 2 ea

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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