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Hsv 1 & 2 API108AA

by Biocare Medical, LLC

Ref API108AA

Hsv 1 & 2 API108AA is an in vitro diagnostic device (EU IVDD general IVD; FDA Class I; FDA product code MVU, Reagents, Specific, Analyte) made by Biocare Medical, LLC, registered in EUDAMED on 31 Aug 2026 (Basic UDI-DI B-00847627024282) and listed in FDA GUDID since 23 Sep 2022 (UDI-DI 00847627024282), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00847627024282 Basic UDI-DI 00847627024282UDI-DIDate31 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847627024282 UDI-DI Date23 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00847627024282 registered 31 Aug 2026 Active
  • FDA GUDID UDI-DI 00847627024282 listed 23 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00847627024282
  2. Registered EUDAMED B-00847627024282

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Herpes Simplex Virus 1&2 (HSV1&2) EUDAMED
Hsv 1 & 2 GUDID
Generic name
Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, antibody
Model / reference
API108AA
Primary DI / UDI-DI
00847627024282
Basic UDI-DI
B-00847627024282
FDA product code
MVU
EMDN code
W0105040302 Hsv 1+2 antibodies - total
GMDN term
Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, antibody
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
864.4020
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, antibody

Similar devices in this category

Other devices filed under HERPES SIMPLEX VIRUS.

Other devices from Biocare Medical, LLC

See all devices from Biocare Medical, LLC →

Properties

  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)