AccessGUDID - DEVICE: LIPASE (LPS) (05055273204247)

GUDID

Device Identifier (DI) Information

Brand Name: LIPASE (LPS)
Version or Model: LI7979
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273204247
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 Lipase in human 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?
53108	Lipase IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of lipase in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase

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: 905fff14-e53e-47b9-870f-2650a739f7f1
Public Version Date: July 06, 2023
Public Version Number: 2
DI Record Publish Date: October 04, 2022