Albumin control slides

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

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

Identifiers

Catalog Number: BSB 3018 FDA UDI
Primary DI / UDI-DI: B502BSB30180 FDA UDI
FDA Product Code: LJG FDA UDI
GMDN Term: Albumin 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: Albumin IVD, control

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

Similar devices

Also classified as Albumin IVD, control.

Eurotrol AlbuTrol — Eurotrol B.V. · Class I
ABX PENTRA MICRO ALB CONTROL L/H — Horiba Abx · Class I
IMMULITE® Systems ALB Calibration Verification Material Albumin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Optilite® Low Level Albumin Control Pack — The Binding Site Group · Class I
IMMULITE® Systems ALB CONTROL Albumin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Eurotrol AlbuTrol — Eurotrol B.V. · Class I
Autokit Micro Albumin Control Set — FUJIFILM WAKO PURE CHEMICAL CORPORATION · Class I
Diazyme — Diazyme Laboratories, Inc.

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 8e83873b-6160-4eb5-b89a-116d680ca42b 34 fields · synced Jun 8, 2026