AccessGUDID - DEVICE: Lipase NG (08058056681782)

GUDID

Device Identifier (DI) Information

Brand Name: Lipase NG
Version or Model: B82715
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B82715
Company Name: SENTINEL CH. SPA

Primary DI Number: 08058056681782
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429572365 *Terms of Use

Device Description: The Lipase NG assay is an in vitro diagnostic test used for the determination on AU480 and AU680 automatic analyzers 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?
53111	Lipase 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 quantitative measurement of lipase in a clinical specimen.	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
Special Storage Condition, Specify: Store between 2 and 8 degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 150 Milliliter

Device Record Status

Public Device Record Key: 74041ecf-a0ee-448e-ae33-f3643ec90f0d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 07, 2016