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Mcm2+top2a

FDA UDI

Class I (US FDA UDI)

by Biocare Medical, Llc

Identity

Trade Name
MCM2+TOP2A FDA UDI
Generic Name
Multiple solid tumour differentiation marker IVD, antibody FDA UDI
Model / Reference
OPAI3181T60 FDA UDI

Identifiers

Primary DI / UDI-DI
00847627029119 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Multiple solid tumour differentiation marker IVD, antibody FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.1860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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: Multiple solid tumour differentiation marker IVD, antibody

Mcm2+top2a by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple solid tumour differentiation marker IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biocare Medical, Llc

Sources (1)

  • FDA UDI 70298e46-51b5-467d-bc7d-763d54bf0d6e 33 fields · synced Jun 8, 2026