AccessGUDID - DEVICE: D LDL/HDL CAL (05055273201239)

GUDID

Device Identifier (DI) Information

Brand Name: D LDL/HDL CAL
Version or Model: CH2673
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CH2673
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273201239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The device is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL cholesterol clearance methods

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?
44696	High density lipoprotein (HDL) cholesterol 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 high density lipoprotein (HDL) cholesterol lipid in a clinical specimen.	Active	false
41728	Low density lipoprotein (LDL) cholesterol 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 low density lipoprotein (LDL) cholesterol lipid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIS	Calibrator, Primary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122126	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, the components are stable for 5 days at +2°C to +8°C and 4 weeks at –20°C when frozen once.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d1ba9567-6039-4b2a-aa7c-d801f46e4761
Public Version Date: March 08, 2022
Public Version Number: 4
DI Record Publish Date: September 16, 2016