AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® IgM Immunoglobulin IgM CC638 (00817302020953)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® IgM Immunoglobulin IgM CC638
Version or Model: CC638
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CC638
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020953
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: IgM (Immunoglobulin M) 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?
48425	Hepatitis G virus immunoglobulin M (IgM) antibody 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 immunoglobulin M (IgM) antibodies to the Hepatitis G virus in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CFF	IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M)

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
Total Volume: 8 Milliliter
Device Size Text, specify: Kit contains 2 Reagent cartridges, 1 user defined paramenter and 1 package insert
Total Volume: 23 Milliliter

Device Record Status

Public Device Record Key: 1db003e5-1227-4559-9961-8c6118dea626
Public Version Date: August 28, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016