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INI-1 (MRQ-27) Mouse Monoclonal Antibody

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 760-4615

by Cell Marque Corporation

Identity

Trade Name
anti-INI-1 (MRQ-27) Mouse Monoclonal Primary Antibody EUDAMED
INI-1 (MRQ-27) Mouse Monoclonal Antibody FDA UDI
Generic Name
INI1 protein IVD, antibody FDA UDI
Device Name
anti-INI-1 (MRQ-27) Mouse Monoclonal Primary Antibody EUDAMED
Model / Reference
760-4615 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00841683101314 EUDAMEDFDA UDI
Basic UDI-DI
008416831760-46152H EUDAMED
FDA Product Code
NJT FDA UDI
EMDN Code
W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
GMDN Term
INI1 protein 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

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: INI1 protein IVD, antibody

INI-1 (MRQ-27) 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 INI1 protein IVD, antibody.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cell Marque Corporation

Sources (2)

  • FDA UDI 1c718831-5ec5-4acc-a3ff-d5579d840e4c 33 fields · synced Jun 18, 2026
  • EUDAMED 99e28b80-42ec-4301-b6c1-5a13c27491bb 61 fields · synced Jun 18, 2026