LH Control Slides

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name: LH Control Slides FDA UDI
Generic Name: Luteinizing hormone (LH) IVD, control FDA UDI
Device Name: LH, Control FDA UDI
Model / Reference: Control Slides, 5 FDA UDI
Description: LH, Control FDA UDI

Identifiers

Catalog Number: BSB 5728 FDA UDI
Primary DI / UDI-DI: B502BSB57280 FDA UDI
FDA Product Code: LJG FDA UDI
GMDN Term: Luteinizing hormone (LH) 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Luteinizing hormone (LH) IVD, control

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

Similar devices

Also classified as Luteinizing hormone (LH) IVD, control.

ADVIA Centaur® LH2 MCM — Siemens Healthcare Diagnostics · Class I
IMMULITE® Systems LH Calibration Verification Material LH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Atellica IM LH MCM — Siemens Healthcare Diagnostics · Class I
LH Control Slides — BIO SB, INC. · Class I

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

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Manufacturer

Manufacturer: Bio Sb, Inc.

Sources (1)

FDA UDI f8d1f58a-5f0c-4e59-9a56-16c1b881216f 34 fields · synced May 30, 2026