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Virotrol 200305A

by Bio-Rad Laboratories

Virotrol 200305A is a Class I device made by Bio-Rad Laboratories, listed in FDA GUDID since 31 Aug 2020 (UDI-DI 03610522207879), 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 Number03610522207879 UDI-DI Date31 Aug 2020ListedStatusListed 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  • Withdrawn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
Virotrol
Generic name
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
Model / Ref / Catalog
200305A
Primary DI / UDI-DI
03610522207879
FDA product code
OHQ
GMDN term
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, controlSARS-CoV-2 total antibody IVD, control

Similar devices

Other devices filed under FDA product code OHQ (Multi-analyte controls unassayed).

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)