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LOLA Ovulation Test

by Alyk, Inc.

LOLA Ovulation Test is a Class I device made by Alyk, Inc., listed in FDA GUDID since 24 Nov 2021 (UDI-DI 00850017666771), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850017666771 UDI-DI Date24 Nov 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Lola
Generic name
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Model / reference
Ovulation Test
Primary DI / UDI-DI
00850017666771
FDA product code
NGE
GMDN term
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Device class
Class I
Regulation number
862.1485
GUDID distribution status
In Commercial Distribution

Related devices

Category: Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

Similar devices

Other devices filed under FDA product code NGE (Test, Luteinizing Hormone (Lh), Over The Counter).

Other devices from Alyk, Inc.

See all devices from Alyk, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)