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Bioclone

FDA UDI

by Ortho-Clinical Diagnostics

Identity

Trade Name
BIOCLONE FDA UDI
Generic Name
Anti-B red blood cell grouping IVD, antibody FDA UDI
Device Name
ANTI-B (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML FDA UDI
Model / Reference
711320 FDA UDI
Description
ANTI-B (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML FDA UDI

Identifiers

Catalog Number
711320 FDA UDI
Primary DI / UDI-DI
10758750003075 FDA UDI
GMDN Term
Anti-B red blood cell grouping IVD, antibody FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Anti-B red blood cell grouping IVD, antibody

Bioclone by Ortho-Clinical Diagnostics — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anti-B red blood cell grouping IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho-Clinical Diagnostics

Sources (1)

  • FDA UDI 901907fe-5204-4dc7-9611-82bc2593f8af 35 fields · synced Jun 8, 2026