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Hepatocyte Specific Antigen Control Slides

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
Hepatocyte Specific Antigen Control Slides FDA UDI
Generic Name
Hepatocyte specific antigen IVD, control FDA UDI
Device Name
Hepatocyte Specific Antigen, Control FDA UDI
Model / Reference
Control Slides, 5 FDA UDI
Description
Hepatocyte Specific Antigen, Control FDA UDI

Identifiers

Catalog Number
BSB 5630 FDA UDI
Primary DI / UDI-DI
B502BSB56300 FDA UDI
FDA Product Code
LJG FDA UDI
GMDN Term
Hepatocyte specific antigen IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 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

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

Category: Hepatocyte specific antigen IVD, control

Hepatocyte Specific Antigen Control Slides by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hepatocyte specific antigen IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio Sb, Inc.

Sources (1)

  • FDA UDI 0f97de3b-5db7-45db-8b61-79fbb17d15a2 34 fields · synced May 31, 2026