Ihc

FDA UDI

Class I (US FDA UDI)

by Slmp, LLC

Identity

Trade Name: IHC FDA UDI
Generic Name: CD99 cell marker IVD, antibody FDA UDI
Device Name: CD99/MIC2, Ewing’s Sarcoma Marker, Clone HO36-1.1, 10mL FDA UDI
Model / Reference: (BTO) RTU CD99 / MIC2, Ewing’s Sarcoma Marker (HO36-1.1) Antibody (10ml) FDA UDI
Description: CD99/MIC2, Ewing’s Sarcoma Marker, Clone HO36-1.1, 10mL FDA UDI

Identifiers

Catalog Number: MM40-10 FDA UDI
Primary DI / UDI-DI: 00810170551055 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: CD99 cell marker IVD, antibody FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.1860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: CD99 cell marker IVD, antibody

Ihc by Slmp, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CD99 cell marker IVD, antibody.

ANTI-CD99 — Biogenex Laboratories, Inc. · Class I
FLEX Mono Mo A-Hu CD99 MIC2 Gene Product Ewing’s Sarcoma Mark Cl 12E7 RTU (Link) — Agilent Technologies Inc. · Class I
Rabbit Monoclonal Anti-Human CD99 Antibody, EP8 — EPITOMICS, INC. · Class I
Anti-CD99 — Biogenex Laboratories, Inc. · Class I
CD99 — BIOCARE MEDICAL, LLC · Class I
CD99 — BIOCARE MEDICAL, LLC · Class I
Rabbit Monoclonal Anti-Human CD99 Antibody, EP8 — EPITOMICS, INC. · Class I
Rabbit Monoclonal Anti-Human CD99 Antibody, EP8 — EPITOMICS, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Slmp, LLC

Sources (1)

FDA UDI ac8a3314-2e18-4c9d-a6cd-3571f51a84de 34 fields · synced May 30, 2026