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Liquid Ranbut (rbt)

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
LIQUID RANBUT (RBT) FDA UDI
Generic Name
Beta-hydroxybutyrate dehydrogenase IVD, kit, spectrophotometry FDA UDI
Device Name
For the quantitative in vitro determination of D-3-Hydroxybutyrate in serum and plasma. FDA UDI
Model / Reference
RB8378 FDA UDI
Description
For the quantitative in vitro determination of D-3-Hydroxybutyrate in serum and plasma. FDA UDI

Identifiers

Catalog Number
RB8378 FDA UDI
Primary DI / UDI-DI
05055273215571 FDA UDI
FDA Product Code
JMK FDA UDI
GMDN Term
Beta-hydroxybutyrate dehydrogenase IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1380 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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 dehydrogenase IVD, kit, spectrophotometry

Liquid Ranbut (rbt) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA UDI f9c72d7f-1e18-4ec3-83bf-71717153ac1b 36 fields · synced May 30, 2026