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Cytokeratin 5 & 14 control slides

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name
Cytokeratin 5 & 14 control slides FDA UDI
Generic Name
Cytokeratin IVD, control FDA UDI
Device Name
Cytokeratin 5 & 14 Control FDA UDI
Model / Reference
Control Slides, 5 FDA UDI
Description
Cytokeratin 5 & 14 Control FDA UDI

Identifiers

Catalog Number
BSB 6631 FDA UDI
Primary DI / UDI-DI
B502BSB66310 FDA UDI
FDA Product Code
LJG FDA UDI
GMDN Term
Cytokeratin 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Cytokeratin IVD, control

Cytokeratin 5 & 14 control slides by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cytokeratin 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 b033f1f8-0660-4e24-90bf-f4e897a54602 34 fields · synced May 30, 2026