HHV-8 (13B10) Mouse Monoclonal Antibody

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 265M-14Model 265M-1X seriesRef 265M-16Ref 265M-15Ref 760-4260Ref 265M-17

by Cell Marque Corporation

Identity

Trade Name: HHV-8 (13B10) Mouse Monoclonal Antibody EUDAMEDFDA UDI
Generic Name: Assay development analyte-specific reagent IVD FDA UDI
Human herpesvirus 8 (HHV8) antigen IVD, antibody FDA UDI
Device Name: HHV-8 (13B10) Mouse Monoclonal Antibody EUDAMED
Model / Reference: 760-4260 EUDAMEDFDA UDI
265M-1X series EUDAMED
265M-14 EUDAMED
265M-16 EUDAMED
265M-15 EUDAMED
265M-17 EUDAMED
265M-16-ASR FDA UDI

Identifiers

Primary DI / UDI-DI: 00841683100539 EUDAMEDFDA UDI
00841683131670 EUDAMED
00841683131694 EUDAMED
00841683131687 EUDAMED
00841683131700 EUDAMED
00841683103899 FDA UDI
Basic UDI-DI: 008416831265M-1D8 EUDAMED
008416831760-426022 EUDAMED
FDA Product Code: MVU FDA UDI
NJT FDA UDI
EMDN Code: W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
GMDN Term: Assay development analyte-specific reagent IVD FDA UDI
Human herpesvirus 8 (HHV8) antigen IVD, antibody FDA UDI

Classification

Device Class: Class C EUDAMED
Class I FDA UDI
Regulation Number: 864.4020 FDA UDI
864.1860 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

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 UDIFDA UDI

Category: Assay development analyte-specific reagent IVD

HHV-8 (13B10) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Cell Marque Corporation

Sources (7)

FDA UDI 33a855b6-ea74-457d-9369-3b50a8380fe2 33 fields · synced Aug 4, 2026
FDA UDI c76438a3-0a15-40d9-b538-379b84ddf626 34 fields · synced May 30, 2026
EUDAMED d7f88add-7fe4-4446-bba2-77399ac5f728 61 fields · synced Jul 8, 2026
EUDAMED 070652b8-8dcf-4de9-bcde-204c9b04a92a 61 fields · synced Jul 9, 2026
EUDAMED 82a2b920-c168-437d-bd39-d91c0dcb79d2 61 fields · synced Jul 10, 2026
EUDAMED 759bf107-ddea-406f-a20d-f3eb05b41c02 61 fields · synced Jul 30, 2026
EUDAMED 6181d57b-e82c-4487-9327-6d52c0f23b09 61 fields · synced Aug 4, 2026