AccessGUDID - DEVICE: Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Method) (06970291985185)

GUDID

Device Identifier (DI) Information

Brand Name: Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Method)
Version or Model: None
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medicalsystem Biotechnology Co., Ltd.

Primary DI Number: 06970291985185
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 545261989 *Terms of Use

Device Description: No description.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
53094	Lactate dehydrogenase 4 (LDH-4) isoenzyme IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of lactate dehydrogenase 4 (LDH-4) isoenzyme in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CFJ	Nad Reduction/Nadh Oxidation, Lactate 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fa0d9a43-77ed-4221-acea-6294f2f9299c
Public Version Date: April 03, 2024
Public Version Number: 2
DI Record Publish Date: March 07, 2019