Skip to content

NeoPATH Pro Universal AP Plus Polymer Kit NPRI10101KT135

by Biocare Medical, LLC

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 Number00847627043047 UDI-DI Date29 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  • Withdrawn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
NeoPATH Pro Universal AP Plus Polymer Kit
Generic Name
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Model / Reference
NPRI10101KT135
Primary DI / UDI-DI
00847627043047
FDA Product Code
PPM
GMDN Term
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Device Class
Class I
Regulation Number
864.4010
GUDID distribution status
In Commercial Distribution

Other devices from Biocare Medical, LLC

See all devices from Biocare Medical, LLC →

Properties

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

Other properties (10)

  • Sterile: No
  • Single Use: 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