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Na 323-27-2

by Alta Diagnostics, Inc.

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

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 Number10858512007188 UDI-DIDate29 Mar 2019ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Multiple-type clinical chemistry analyte profile IVD, control
Model / Ref / Catalog
323-27-2
Primary DI / UDI-DI
10858512007188
FDA Product Code
DFI
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, control
Device Class
Class I
Regulation Number
866.5860
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 5 Milliliter

Related devices

Category: Multiple-type clinical chemistry analyte profile IVD, control

Other devices from Alta Diagnostics, Inc.

See all devices from Alta Diagnostics, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No