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PE anti-human TdT 989916

by Biolegend, 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 Number00810034704009 UDI-DI Date22 Dec 2025ListedStatusListed 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  • Withdrawn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
PE anti-human TdT
Generic Name
Assay development analyte-specific reagent IVD
Model / Ref / Catalog
989916
Primary DI / UDI-DI
00810034704009
FDA Product Code
MVU
GMDN Term
Assay development analyte-specific reagent IVD
Device Class
Class I
Regulation Number
864.4020
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 500 Microliter

Other devices from Biolegend, Inc.

See all devices from Biolegend, Inc. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • 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
  • Serial Number: No
  • Manufacturing Date: No