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Bioclone

FDA UDI

by Ortho-Clinical Diagnostics

Identity

Trade Name
BIOCLONE FDA UDI
Generic Name
Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination FDA UDI
Device Name
Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 100X10ML Green FDA UDI
Model / Reference
716910 FDA UDI
Description
Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 100X10ML Green FDA UDI

Identifiers

Catalog Number
716910 FDA UDI
Primary DI / UDI-DI
10758750003600 FDA UDI
GMDN Term
Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination 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: Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination

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

Similar devices

Also classified as Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination.

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 c402e8f3-095e-4102-aadf-a2696e9d30df 35 fields · synced Jun 7, 2026