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Amplim A8178-30+7

by Amplim, LLC

Amplim A8178-30+7 is a Class II device made by Amplim, LLC, listed in FDA GUDID since 9 Jan 2025 (UDI-DI 00810477026300), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810477026300 UDI-DI Date9 Jan 2025ListedStatusListed 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  • Withdrawn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
Amplim
Generic name
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Model / reference
A8178-30+7
Description
AMPLIM Ovulation Test Kit (30 Ovulation Test+ 7 Early Pregnancy Tests)
Primary DI / UDI-DI
00810477026300
FDA product code
LCX, NGE
GMDN term
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.1155, 862.1485
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinicalLuteinizing hormone (LH) IVD, kit, rapid ICT, clinical

Similar devices

Other devices filed under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter).

Other devices from Amplim, LLC

See all devices from Amplim, LLC →

Properties

  • Single use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)