AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D (00817302020151)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D
Version or Model: CC204-100-D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC204-100-D
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020151
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: Lp(a) (Lipoprotein (a) 2 x 60 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?
55018	LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to low density lipoprotein (anti-LDL) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DFC	LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL
JIT	CALIBRATOR, SECONDARY
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

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
Special Storage Condition, Specify: Unopened reagents are stable to expiration date when stored at 2 to 8°C
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Kit contains 2 reagent cartridges 1 reagent package insert and 1 user defined parameters package insert
Total Volume: 4 Milliliter
Total Volume: 15 Milliliter

Device Record Status

Public Device Record Key: 6d9f7b3a-f066-44fb-b866-4c23577cf40e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016