β-Hydroxybutyrate 21 Tri-Level Controls

FDA UDI

Class I (US FDA UDI)

by DiaSys Diagnostic Systems GmbH

Identity

Trade Name: β-Hydroxybutyrate 21 Tri-Level Controls FDA UDI
Generic Name: Beta-hydroxybutyrate IVD, control FDA UDI
Device Name: For use as controls in quantitative procedures for β-Hydroxybutyrate FDA UDI
Model / Reference: 595709943085 FDA UDI
Description: For use as controls in quantitative procedures for β-Hydroxybutyrate FDA UDI

Identifiers

Catalog Number: 595709943085 FDA UDI
Primary DI / UDI-DI: 04051839002914 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Beta-hydroxybutyrate IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 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

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

β-Hydroxybutyrate 21 Tri-Level Controls by DiaSys Diagnostic Systems GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Beta-hydroxybutyrate IVD, control.

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TDM/B-Hydroxybutyrate Bi-Level Controls — STANBIO LABORATORY, L.P. · Class I
Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
STAT-Site B-HB Controls — STANBIO LABORATORY, L.P. · Class I
CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
CARDINAL HEALTH — Cardinal Health 200, LLC · 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: DiaSys Diagnostic Systems GmbH

Sources (1)

FDA UDI d9ccb738-bea7-415c-8c0b-5ebe4552a0c8 35 fields · synced Jun 1, 2026