Tau control slides

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name: Tau control slides FDA UDI
Generic Name: Tau protein IVD, control FDA UDI
Device Name: Tau Control FDA UDI
Model / Reference: Control Slides, 5 FDA UDI
Description: Tau Control FDA UDI

Identifiers

Catalog Number: BSB 3433 FDA UDI
Primary DI / UDI-DI: B502BSB34330 FDA UDI
FDA Product Code: LJG FDA UDI
GMDN Term: Tau protein 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Tau protein IVD, control

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

Similar devices

Also classified as Tau protein IVD, control.

VALIDATE — LGC Clinical Diagnostics, Inc. · Class I
CalCheck Phospho-Tau (181P) — Roche Diagnostics Corp. · Class I
PreciControl Phospho-Tau (181P) — Roche Diagnostics Corp. · Class I
VALIDATE — LGC Clinical Diagnostics, Inc. · Class I
PreciControl Total-Tau — Roche Diagnostics Corp. · Class I
VALIDATE — LGC Clinical Diagnostics, Inc. · Class I
CalChecks Total-Tau — Roche Diagnostics Corp. · Class I
Lumipulse pTau 217 Plasma Controls — Fujirebio Europe · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Bio Sb, Inc.

Sources (1)

FDA UDI ba5261d2-45f3-4eba-a6c5-aa291108b84b 34 fields · synced May 30, 2026