CD163 (MRQ-26) Mouse Monoclonal Antibody

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 163M-14Model 163M-1X seriesRef 163M-16Ref 760-4437Ref 163M-15

by Cell Marque Corporation

Identity

Trade Name: CD163 (MRQ-26) Mouse Monoclonal Antibody EUDAMEDFDA UDI
Generic Name: CD163 cell marker IVD, antibody FDA UDI
Device Name: CD163 (MRQ-26) Mouse Monoclonal Antibody EUDAMED
Model / Reference: 760-4437 EUDAMEDFDA UDI
163M-14 EUDAMEDFDA UDI
163M-15 EUDAMEDFDA UDI
163M-16 EUDAMEDFDA UDI
163M-1X series EUDAMED

Identifiers

Primary DI / UDI-DI: 00841683100942 EUDAMEDFDA UDI
00841683125273 EUDAMEDFDA UDI
00841683125280 EUDAMEDFDA UDI
00841683125297 EUDAMEDFDA UDI
Basic UDI-DI: 008416831163M-1CD EUDAMED
008416831760-44372H EUDAMED
FDA Product Code: NJT FDA UDI
EMDN Code: W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
GMDN Term: CD163 cell marker IVD, antibody FDA UDI

Classification

Device Class: Class C EUDAMED
Class I FDA UDI
Regulation Number: 864.1860 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: 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

Yes

FDA UDIFDA UDI

Category: CD163 cell marker IVD, antibody

CD163 (MRQ-26) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as CD163 cell marker IVD, antibody.

Tinto CD163, RMab — BIO SB, INC. · Class I
Tinto CD163, RMab — BIO SB, INC. · Class I
Novocastra — Leica Biosystems Newcastle, Limited · Class I
CD163 — BIOCARE MEDICAL, LLC · Class I
CD163 PURE — IQ Products B.V. · Class I
Rabbit Monoclonal Anti-Human CD163 Antibody, EP324 — EPITOMICS, INC. · Class I
Mouse Monoclonal Anti-Human CD163(MX081) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
BOND — Leica Biosystems Newcastle, Limited · Class I

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 (8)

FDA UDI 93ba1718-2eec-4e69-8150-ebe31831b9fb 33 fields · synced Jul 31, 2026
FDA UDI 0fa23815-2947-453a-ae00-b80125360e10 33 fields · synced May 30, 2026
FDA UDI c0f11772-052c-4989-80c1-d70278667b48 33 fields · synced May 30, 2026
FDA UDI 78cb7276-9175-4a98-a457-e842228492f9 33 fields · synced May 30, 2026
EUDAMED 7b0d8eda-648f-48c1-aa38-7a7229545b05 61 fields · synced Jul 14, 2026
EUDAMED 424f14e6-0c6e-46d1-bdf5-2ddb55d39d2d 61 fields · synced Jul 14, 2026
EUDAMED 1c246677-373b-4f78-91e6-263b5b4ff36c 61 fields · synced Jul 21, 2026
EUDAMED d2b08387-f78b-47c6-b732-f62824149172 61 fields · synced Jul 31, 2026