Exact Diagnostics 12020069

by Exact Diagnostics

Exact Diagnostics 12020069 is a Class I device made by Exact Diagnostics, listed in FDA GUDID since 27 Aug 2024 (UDI-DI 03610522384389), 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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number03610522384389 UDI-DI	Date27 Aug 2024Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 03610522384389

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Exact Diagnostics
Generic name: Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
Model / Ref / Catalog: 12020069

Primary DI / UDI-DI: 03610522384389
FDA product code: OHQ
GMDN term: Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Device class: Class I
Regulation number: 862.1660
GUDID distribution status: In Commercial Distribution

Other devices from Exact Diagnostics

See all devices from Exact Diagnostics →

Properties

Single use
Premarket exempt
Lot / batch number
Expiration date

Other properties (11, all answered No)