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β-Hydroxybutyrate 21 FS

FDA UDI

Class I (US FDA UDI)

by DiaSys Diagnostic Systems GmbH

Identity

Trade Name
β-Hydroxybutyrate 21 FS FDA UDI
Generic Name
Beta-hydroxybutyrate IVD, kit, spectrophotometry FDA UDI
Device Name
For the quantitative determination of beta-hydroxybutyrate in human serum or plasma. FDA UDI
Model / Reference
137119943018 FDA UDI
Description
For the quantitative determination of beta-hydroxybutyrate in human serum or plasma. FDA UDI

Identifiers

Catalog Number
137119943018 FDA UDI
Primary DI / UDI-DI
04051839002891 FDA UDI
FDA Product Code
JIN FDA UDI
GMDN Term
Beta-hydroxybutyrate IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1435 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Beta-hydroxybutyrate IVD, kit, spectrophotometry

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

Similar devices

Also classified as Beta-hydroxybutyrate IVD, kit, spectrophotometry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DiaSys Diagnostic Systems GmbH

Sources (1)

  • FDA UDI 8f6c5c34-0279-4eff-8e26-16588b337303 35 fields · synced May 31, 2026