AccessGUDID - DEVICE: APO CAL (05055273204414)

GUDID

Device Identifier (DI) Information

Brand Name: APO CAL
Version or Model: LP3023
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LP3023
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273204414
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: This product is intended for in-vitro use in the calibration of Apolipoprotein A-I and Apolipoprotein B assays.

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?
59060	Multiple apolipoprotein IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple apolipoprotein lipid analytes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIX	Calibrator, Multi-Analyte Mixture

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023158	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Once reconstituted APO A-I and APO B are stable for 7 days at +2°C to +8°C, and 1 month at -20°C when frozen once.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ee4364e1-bc7a-4609-93a0-28d8e7de0ea4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016