AccessGUDID - DEVICE: LDH Reagent Set (00812137012005)

GUDID

Device Identifier (DI) Information

Brand Name: LDH Reagent Set
Version or Model: R1 x 500mL, R2 x 125mL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 501-413
Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Primary DI Number: 00812137012005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 048144997 *Terms of Use

Device Description: For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Increased levels of LD are associated with myocardial infarction. Levels reach a maximum approximately 48 hours after the onset of pain and persist about ten days. The degree of elevation is of value in assessing the extent of damage and in developing a prognosis. LD elevations are also observed in liver disease, pernicious anemia, in some cases of renal disease, and in some cases of skeletal muscle trauma.

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:	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?
53089	Lactate dehydrogenase 5 (LDH-5) 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 5 (LDH-5) 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: No 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: 04371e3e-0f00-4c0a-9eaa-bd9123c5623a
Public Version Date: April 03, 2024
Public Version Number: 3
DI Record Publish Date: October 12, 2016