Ihc

FDA UDI

Class I (US FDA UDI)

by Slmp, LLC

Identity

Trade Name: IHC FDA UDI
Generic Name: Homeobox protein CDX-2 IVD, antibody FDA UDI
Device Name: CDX2, Clone EP25, 100mL FDA UDI
Model / Reference: (BTO) RTU CDX2 (EP25) 100 ml FDA UDI
Description: CDX2, Clone EP25, 100mL FDA UDI

Identifiers

Catalog Number: RM160-100 FDA UDI
Primary DI / UDI-DI: 00810170551826 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Homeobox protein CDX-2 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: Homeobox protein CDX-2 IVD, antibody

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

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CDX2 — BIOCARE MEDICAL, LLC · 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 939383bf-1e88-44ba-9fc0-dfd0713e37ac 34 fields · synced May 31, 2026