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Tinto MiTF, C5 and D5, MMab

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref BSB 6247

by Bio SB Inc

Identity

Trade Name
Tinto MiTF, C5 and D5, MMab EUDAMED
Tinto MiTF MMab FDA UDI
Generic Name
Microphthalmia-associated transcription factor (MITF) IVD, antibody FDA UDI
Device Name
Tinto MiTF, C5 and D5, MMab EUDAMED
Anti-MiTF is cocktail of two mouse monoclonal antibodies derived from cell culture supernatant that are concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
Model / Reference
BSB 6247 EUDAMED
Predilute, 3 ml FDA UDI
Description
Anti-MiTF is cocktail of two mouse monoclonal antibodies derived from cell culture supernatant that are concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI

Identifiers

Catalog Number
BSB 6247 FDA UDI
Primary DI / UDI-DI
B502BSB62470 EUDAMEDFDA UDI
Basic UDI-DI
B-B502BSB62470 EUDAMED
FDA Product Code
NJT FDA UDI
EMDN Code
W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
GMDN Term
Microphthalmia-associated transcription factor (MITF) IVD, antibody 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

Tinto MiTF, C5 and D5, MMab 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 092ce384-f983-4943-9ffe-7f23bb95177b 61 fields · synced Jul 23, 2026
  • FDA UDI 71f0e7a9-b4c4-4194-827e-d02455fb5510 34 fields · synced May 30, 2026