AccessGUDID - DEVICE: Lp(a) Cal Set (08058056680228)

GUDID

Device Identifier (DI) Information

Brand Name: Lp(a) Cal Set
Version or Model: 11522D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11522D
Company Name: SENTINEL CH. SPA

Primary DI Number: 08058056680228
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429572365 *Terms of Use

Device Description: Lp(a) Cal Set should be used as calibration curve for the Lp(a) Ultra test. Use the Calibrator according to the indicated analytical procedure.

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?
41417	Lipoprotein A IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIT	Calibrator, Secondary

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
No Device Sizes

Device Record Status

Public Device Record Key: 0b8a1658-93a7-4e99-84b9-fb921667c06f
Public Version Date: March 25, 2024
Public Version Number: 1
DI Record Publish Date: March 15, 2024