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IHC (BTO) RTU IgG Antibody (10ml)

by Slmp, LLC

IHC (BTO) RTU IgG Antibody (10ml) (RP08-10) is a Class I device made by Slmp, LLC, listed in FDA GUDID since 6 Mar 2025 (UDI-DI 00810170552090), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810170552090 UDI-DI Date6 Mar 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Ihc
Generic name
Total immunoglobulin G (IgG total) IVD, antibody
Model / Ref / Catalog
(BTO) RTU IgG Antibody (10ml), RP08-10
Primary DI / UDI-DI
00810170552090
FDA product code
NJT
GMDN term
Total immunoglobulin G (IgG total) IVD, antibody
Device class
Class I
Regulation number
864.1860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total immunoglobulin G (IgG total) IVD, antibody

Similar devices

Other devices filed under FDA product code NJT (Immunohistochemistry Reagents And Kits).

Other devices from Slmp, LLC

See all devices from Slmp, LLC →

Properties

  • Single use
  • Premarket exempt
Other properties (13, all answered No)