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NKX2.2, EP336, RMab

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref BSB 3110

by Bio SB Inc

Identity

Trade Name
NKX2.2, EP336, RMab EUDAMED
NKX2.2 RMab FDA UDI
Generic Name
Gastrointestinal cancer genotyping IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
NKX2.2, EP336, RMab EUDAMED
NKX2.2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
Model / Reference
BSB 3110 EUDAMED
Concentrate, 0.5 ml FDA UDI
Description
NKX2.2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI

Identifiers

Catalog Number
BSB 3110 FDA UDI
Primary DI / UDI-DI
B502BSB31100 EUDAMEDFDA UDI
Basic UDI-DI
B-B502BSB31100 EUDAMED
FDA Product Code
NJT FDA UDI
EMDN Code
W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
GMDN Term
Gastrointestinal cancer genotyping IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
864.1860 FDA UDI
Market of Registration
Sweden 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

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

NKX2.2, EP336, RMab by Bio Sb, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio SB Inc
EUDAMED SRN
US-MF-000036462
Authorised Representative
QAdvis EAR AB SE-AR-000001599

Sources (2)

  • EUDAMED 834589bd-6b02-4d6d-962b-36bc07455a8e 61 fields · synced Jun 19, 2026
  • FDA UDI 45a69b7d-8d10-4f14-b441-874e61b5b843 34 fields · synced May 30, 2026