UDI device identifier

Signature Care One Step Pregnancy Test

UDI device identifier 00021130788361 · BETTER LIVING BRANDS LLC

Key facts

Primary DI 00021130788361
Brand name Signature Care
Version or model One Step Pregnancy Test
Company BETTER LIVING BRANDS LLC
DUNS number 080349866
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 Oct 26, 2016
Version date Jul 6, 2023
Description FPPL Signature Care SPS +/- (ER)

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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