Fisherbrand

FDA UDI

Class I (US FDA UDI)

by Fisher Scientific Company L.l.c.

Identity

Trade Name: Fisherbrand FDA UDI
Generic Name: Beta-hydroxybutyrate IVD, control FDA UDI
Device Name: BHB BI-LEVEL CONTROL FDA UDI
Model / Reference: FH2465-605 FDA UDI
Description: BHB BI-LEVEL CONTROL FDA UDI

Identifiers

Catalog Number: 23001179 FDA UDI
Primary DI / UDI-DI: 00613647025284 FDA UDI
FDA Product Code: DIF FDA UDI
GMDN Term: Beta-hydroxybutyrate IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.3280 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Beta-hydroxybutyrate IVD, control

Fisherbrand by Fisher Scientific Company L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Beta-hydroxybutyrate IVD, control.

TDM/B-Hydroxybutyrate Tri-Level Controls — STANBIO LABORATORY, L.P. · Class I
CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
Diazyme — Diazyme Laboratories, Inc.
TDM/B-Hydroxybutyrate Bi-Level Controls — STANBIO LABORATORY, L.P. · Class I
STAT-Site B-HB Controls — STANBIO LABORATORY, L.P. · Class I
CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
β-Hydroxybutyrate 21 Tri-Level Controls — DiaSys Diagnostic Systems GmbH · Class I
β-Hydroxybutyrate 21 Bi-Level Controls — DiaSys Diagnostic Systems GmbH · 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: Fisher Scientific Company L.l.c.

Sources (1)

FDA UDI 1bd1c382-bc31-4da3-bbd0-5a7c6886735b 35 fields · synced Jun 8, 2026