AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® SERUM CAL KIT Product No. 28200 (00817302023176)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® SERUM CAL KIT Product No. 28200
Version or Model: 28200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 28200
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302023176
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: Serum Calibrator

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:	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?
47868	Multiple-type clinical chemistry analyte profile IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE

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: Unreconstituted serum is stable up to expiration date.
Special Storage Condition, Specify: Once reconstituted, the components of the Calibration Sera are stable for 8 hours at 25°C, 7 days at 2-8°C and 1 month at -20°C when frozen once.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter
Device Size Text, specify: Kit contains 6 ca-5 bottles, 1 reagent package insert and 1 setpoint package insert

Device Record Status

Public Device Record Key: bf391dae-af42-43f5-a20b-bf079d668f51
Public Version Date: August 14, 2023
Public Version Number: 3
DI Record Publish Date: April 10, 2017