AccessGUDID - DEVICE: Lipase Color Liquid (08058056680617)

GUDID

Device Identifier (DI) Information

Brand Name: Lipase Color Liquid
Version or Model: 17401B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 17401B
Company Name: SENTINEL CH. SPA

Primary DI Number: 08058056680617
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429572365 *Terms of Use

Device Description: The Lipase Color Liquid is an In Vitro Diagnostic test used for the determination of the lipase activity in serum and plasma by kinetic colorimetric method. The assay is intended for professional use only.

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):	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 [?]
K961179	000

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
Special Storage Condition, Specify: Store between 2 and 8 degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 49 Milliliter

Device Record Status

Public Device Record Key: e952378d-9a0d-4725-8813-bb4bb4350579
Public Version Date: July 06, 2023
Public Version Number: 4
DI Record Publish Date: January 16, 2017