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ADVIA® Chemistry MYO Myoglobin Reagents 10361939

by Siemens Healthcare Diagnostics Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number00630414000190 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2899-2016 FDA Class II initiated 8 Aug 2016

    Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ADVIA® Chemistry MYO Myoglobin Reagents
Generic Name
Myoglobin IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
10361939, 4862455
Description
Myoglobin - ADVIA Chem. - RGT - 2x100 tests
Primary DI / UDI-DI
00630414000190
510(k) Number
FDA Product Code
DDR
GMDN Term
Myoglobin IVD, kit, nephelometry/turbidimetry
Device Class
Class II
Regulation Number
866.5680
GUDID distribution status
Not in Commercial Distribution

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Properties

  • Lot / Batch Number
  • Expiration 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
  • Serial Number: No
  • Manufacturing Date: No