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MAGLUMI 25-OH Vitamin D 130661601M

by Shenzhen New Industries Biomedical Engineering Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number06947145547486 UDI-DI Date15 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MAGLUMI 25-OH Vitamin D
Generic Name
Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
130661601M
Primary DI / UDI-DI
06947145547486
510(k) Number
FDA Product Code
MRG
GMDN Term
Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
Device Class
Class II
Regulation Number
862.1825
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K232587)

Other devices from Shenzhen New Industries Biomedical Engineering Co., Ltd.

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Properties

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

Other properties (10)

  • 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
  • Manufacturing Date: No