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AccuDiag™ 17-alpha-OH Progesterone ELISA DACD1292-15

by Diagnostic Automation, 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00894175000770 UDI-DI Date27 Jan 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AccuDiag™ 17-alpha-OH Progesterone ELISA
Generic Name
17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
DACD1292-15, 1292-15
Primary DI / UDI-DI
00894175000770
FDA Product Code
JLX
GMDN Term
17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)
Device Class
Class I
Regulation Number
862.1395
GUDID distribution status
In Commercial Distribution

Other devices from Diagnostic Automation, Inc.

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Properties

  • Single Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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