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Spermac Stain - Fixative 15515

by Vitrolife AB

Spermac Stain - Fixative 15515 is a Class II device made by Vitrolife AB, listed in FDA GUDID since 23 Apr 2018 (UDI-DI 00805360018425), 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 Number00805360018425 UDI-DI Date23 Apr 2018ListedStatusListed 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  • Withdrawn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
Spermac Stain - Fixative
Generic name
10% Formaldehyde solution IVD
Model / reference
15515
Primary DI / UDI-DI
00805360018425
FDA product code
POV
GMDN term
10% Formaldehyde solution IVD
Device class
Class II
Regulation number
864.5220
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code POV (Semen Analysis Device).

Other devices from Vitrolife AB

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Properties

  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)