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FINDER Flu A&B/SARS-CoV-2 Test 100-000068

by Baebies Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00819704020425 UDI-DI Date1 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
FINDER Flu A&B/SARS-CoV-2 Test
Generic Name
Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
100-000068
Primary DI / UDI-DI
00819704020425
510(k) Number
FDA Product Code
QOF
GMDN Term
Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Device Class
Class II
Regulation Number
866.3981
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252269)

Other devices from Baebies Inc.

See all devices from Baebies Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No