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Myrna-1000

by Inflammatix, 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 Number00850028489017 UDI-DI Date30 Apr 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  • Withdrawn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
Myrna
Generic Name
Isothermal nucleic acid amplification analyser IVD, point-of-care
Model / Ref / Catalog
MYRNA-1000
Primary DI / UDI-DI
00850028489017
510(k) Number
FDA Product Code
OOI
GMDN Term
Isothermal nucleic acid amplification analyser IVD, point-of-care
Device Class
Class II
Regulation Number
862.2570
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K241676)

Other devices from Inflammatix, Inc.

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No