Simplexa™ Group A Strep Positive…: CE/IVDD IVD General

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD EUDAMED	NumberB-20816101025576 Basic UDI-DI 20816101025576UDI-DI	Date5 Oct 2026Registered	StatusActive
United States	GUDID listing GUDID	Number20816101025576 UDI-DI	Date22 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK143651	Date18 Mar 2015Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-20816101025576 — open Devices and search for it
AccessGUDID record UDI-DI 20816101025576
FDA 510(k) database 510(k) number K143651

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-20816101025576 registered 5 Oct 2026 Active
FDA 510(k) K143651 decided 18 Mar 2015 Active
FDA GUDID UDI-DI 20816101025576 listed 22 Sep 2016 Listed

Recalls

1 recall · FDA

- Terminated Z-1274-2016 FDA Class I initiated 10 Feb 2016
Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.

Timeline

4 dated events

18 Mar 2015 Cleared FDA 510(k) K143651
10 Feb 2016 Recall initiated FDA recalls Z-1274-2016
22 Sep 2016 Listed FDA GUDID 20816101025576
5 Oct 2026 Registered EUDAMED B-20816101025576

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/IVDD Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Simplexa™ Group A Strep Positive Control Pack
Generic name: Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
Model / Ref / Catalog: MOL2860

Primary DI / UDI-DI: 20816101025576
Basic UDI-DI: B-20816101025576
510(k) Number: K143651
FDA product code: PGX
EMDN code: W0105080808 All infectious diseases controls - nat
GMDN term: Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

Device class: Class IVD General EUDAMED
Class II GUDID
Regulation number: 866.2680
EU registration type: Legacy device (under a directive)
EU market of registration: Italy
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IVD General	GUDID Class II

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