AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® LDL DIRECT REAGENT CC667 (00817302022667)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® LDL DIRECT REAGENT CC667
Version or Model: CC667
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CC667
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302022667
Issuing Agency: GS1
Commercial Distribution End Date: August 27, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: LDLD (LDL Cholesterol Direct) w/ cal 2 x 200 tests

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:	Yes
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?
53395	Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBR	LDL & VLDL PRECIPITATION, HDL
MRR	SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, Specify: Onboard the SYNCHRON: LDL is stable for 30 days.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 19 Milliliter
Total Volume: 52 Milliliter
Total Volume: 3 Milliliter
Device Size Text, specify: Kit contains 2 filled reagent cartridges 1 filled HDL/LDL Calibrator bottle 2 package inserts with LDL 1 and LDL 2 User Defined Parameters printed on the back, and 1 HDL/LDL Calibrator package insert

Device Record Status

Public Device Record Key: cd510ead-9dd9-40db-b56d-646bdebe52eb
Public Version Date: July 06, 2023
Public Version Number: 2
DI Record Publish Date: August 27, 2018