AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300 (00817302022155)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300
Version or Model: BL300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BL300
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302022155
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: HbA1c (Hemoglobin A1c Direct) 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?
57269	Free plasma haemoglobin IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free plasma haemoglobin in a clinical specimen, using an enzyme immunohistochemistry method. Free haemoglobin in plasma is indicative of red blood cell damage, and its detection is used as an aid in the diagnosis of haemolytic conditions (e.g., intravascular haemolysis, sickle cell anaemia, malaria) or to identify incompatible blood transfusions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCP	ASSAY, GLYCOSYLATED HEMOGLOBIN

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 on board a clinical analyzer for 30 days
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

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10 Milliliter
Device Size Text, specify: Kit contains 2 R1, 2 R2 and 1 package insert
Total Volume: 25 Milliliter

Device Record Status

Public Device Record Key: d35932b6-29cb-46cf-97bb-caded6d425f8
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: September 01, 2016