AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT BL-632 (00817302020878)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT BL-632
Version or Model: BL632
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BL632
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020878
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: APO A1 (Apolipoprotein A1) 2 x 100 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?
53443	Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of apolipoprotein A-I (Apo A1) lipid in a clinical specimen, using a nephelometry/turbidimetry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DER	ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Kit contains 2 R1 and 2 R2 bottles and 1 package insert
Total Volume: 8 Milliliter
Total Volume: 23 Milliliter

Device Record Status

Public Device Record Key: 50ab973a-cafb-4294-a832-146654357dda
Public Version Date: August 28, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016