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Ihc

FDA UDI

Class I (US FDA UDI)

by Slmp, LLC

Identity

Trade Name
IHC FDA UDI
Generic Name
Melanoma-associated antigen (MAGE) IVD, antibody FDA UDI
Device Name
Melanoma, Clone HMB45, 6mL (Manual Use) FDA UDI
Model / Reference
(BTO) Manual Melanoma (HMB45) Antibody (6ml) FDA UDI
Description
Melanoma, Clone HMB45, 6mL (Manual Use) FDA UDI

Identifiers

Catalog Number
MM100-6 FDA UDI
Primary DI / UDI-DI
00810170550317 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Melanoma-associated antigen (MAGE) 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Melanoma-associated antigen (MAGE) IVD, antibody

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

Similar devices

Also classified as Melanoma-associated antigen (MAGE) IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Slmp, LLC

Sources (1)

  • FDA UDI f25f07b0-a981-4eb7-8185-017f2553c173 34 fields · synced Jun 8, 2026