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Exact Diagnostics B19L101

by Exact Diagnostics

Exact Diagnostics B19L101 is a Class I device made by Exact Diagnostics, listed in FDA GUDID since 24 Sep 2018 (UDI-DI 00812242030482), 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 Number00812242030482 UDI-DI Date24 Sep 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  • Withdrawn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
Exact Diagnostics
Generic name
Parvovirus B19 nucleic acid IVD, control
Model / Ref / Catalog
B19L101
Primary DI / UDI-DI
00812242030482
FDA product code
OHQ
GMDN term
Parvovirus B19 nucleic acid IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Parvovirus B19 nucleic acid IVD, control

Similar devices

Also classified as Parvovirus B19 nucleic acid IVD, control.

Similar devices

Other devices filed under FDA product code OHQ (Multi-Analyte Controls Unassayed).

Other devices from Exact Diagnostics

See all devices from Exact Diagnostics →

Properties

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