AccessGUDID - DEVICE: LIQUID RANBUT (RBT) (05055273215571)

GUDID

Device Identifier (DI) Information

Brand Name: LIQUID RANBUT (RBT)
Version or Model: RB8378
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RB8378
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273215571
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: For the quantitative in vitro determination of D-3-Hydroxybutyrate in serum and plasma.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59072	Beta-hydroxybutyrate dehydrogenase IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of beta-hydroxybutyrate dehydrogenase in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JMK	Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f9c72d7f-1e18-4ec3-83bf-71717153ac1b
Public Version Date: July 06, 2023
Public Version Number: 2
DI Record Publish Date: September 23, 2022