← Back to catalogue

INI-1 (MRQ-27) Mouse Monoclonal Antibody

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 272M-14Model 272M-1X series

by Cell Marque Corporation

Identity

Trade Name
INI-1 (MRQ-27) Mouse Monoclonal Antibody EUDAMEDFDA UDI
Generic Name
INI1 protein IVD, antibody FDA UDI
Device Name
INI-1 (MRQ-27) Mouse Monoclonal Antibody EUDAMED
Model / Reference
272M-14 EUDAMEDFDA UDI
272M-1X series EUDAMED
272M-15 FDA UDI

Identifiers

Primary DI / UDI-DI
00841683120636 EUDAMEDFDA UDI
00841683120643 FDA UDI
Basic UDI-DI
008416831272M-1CW 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

No

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

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

Manufacturer

Manufacturer
Cell Marque Corporation

Sources (3)

  • FDA UDI b514a100-a536-443c-9f1d-8460ece67425 33 fields · synced Jul 15, 2026
  • FDA UDI c56db9ae-03da-4ab8-a970-84c8e13980ca 33 fields · synced May 30, 2026
  • EUDAMED ca8527a8-17ca-407e-94f7-b0c2ce1dcd78 61 fields · synced Jul 15, 2026