UDI device identifier

TopCare Health 6 Days Sooner Pregnancy Test

UDI device identifier 00036800028357 · Topco Associates, LLC

Key facts

Primary DI 00036800028357
Brand name TopCare Health
Version or model 6 Days Sooner Pregnancy Test
Company Topco Associates, LLC
DUNS number 072943876
Product code LCX
GMDN term Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Premarket submission K213379
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Jul 13, 2026
Version date Jul 21, 2026
Description Topco (TopCare) TPS 6 Day Blue

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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