KBA.62 (KBA.62) Mouse Monoclonal Antibody

FDA UDI

Class I (US FDA UDI)

by Cell Marque Corporation

Identity

Trade Name: KBA.62 (KBA.62) Mouse Monoclonal Antibody FDA UDI
Generic Name: Melanoma specific protein IVD, antibody FDA UDI
Model / Reference: 366M-95 FDA UDI

Identifiers

Primary DI / UDI-DI: 00841683139294 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Melanoma specific protein 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Melanoma specific protein IVD, antibody

KBA.62 (KBA.62) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Melanoma specific protein IVD, antibody.

Dako — Agilent Technologies Inc. · Class I
ihcDirect® PRAME Ab-Enh 15mL — NOVODIAX, INC. · Class I
BOND — Leica Biosystems Newcastle, Limited · Class I
ANTI-MELANOMA — Biogenex Laboratories, Inc. · Class I
Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
ihcDirect® PRAME Ab Conjugate 5mL — NOVODIAX, INC. · Class I
Q-STAIN® QSX-Enh PRAME — NOVODIAX, INC. · Class I
Tissue-Tek Genie® — Sakura Finetek USA, 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Cell Marque Corporation

Sources (1)

FDA UDI 9197aba2-3653-4bee-95d1-73bb81f13328 33 fields · synced May 30, 2026