FDA.reportPublic FDA data

CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300

Primary DI
00817302022155
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
BL300
Catalog number
BL300
Device description
HbA1c (Hemoglobin A1c Direct) 2 x 100 tests
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCPASSAY, GLYCOSYLATED HEMOGLOBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817302022155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302022155008173020221558173020221550817302022155

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin detection IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of haemoglobin in a clinical specimen using an enzyme immunohistochemistry method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume10Milliliter
Total Volume25Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Reagent is stable on board a clinical analyzer for 30 days
Special Storage Condition, Specify00Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)471-7272ContactSales@CarolinaChemistries.com

Regulatory Flags#

DUNS number
962385787
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817302022353Carolina Liquid Chemistries Corp. Basic Multi-Drug Control SetCC4492023-03-27
00817302022339Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYANCLCE11062023-03-10
00817302022346Carolina Liquid Chemistries Corp. Fentanyl Detection KitCLCF650252023-03-10
00817302024678CAROLINA LIQUID CHEMISTRIES CORP.® OXIDANT REAGENT CC445CC445CC4452022-12-03
00817302024654Caldon Biotech Aldolase ReagentCALD-015CALD-0152022-11-30
00817302024661Caldon Biotech Serum Aldolase ControlsCOAL-015COAL-0152022-11-30
00817302024647CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240AU-240AU-2402022-10-18
00817302024104CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-220AU-220AU-2202022-08-19
00817302024111CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218AU-240AU-2402022-08-19
00817302024128CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT AU-618AU-618AU-6182022-08-19
00817302024135CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT AU-621AU-621AU-6212022-08-19
00817302024142CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661AU-661AU-6612022-08-19
00817302024159CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT BL209BL209BL2092022-08-19
00817302024166CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT BL211BL211BL2112022-08-19
00817302024173CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT BL212BL212BL2122022-08-19
00817302024180CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDE REAGENT KIT BL213BL213BL2132022-08-19
00817302024197CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218BL218BL2182022-08-19
00817302024203CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT BL220BL220BL2202022-08-19
00817302024210CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT BL240BL240BL2402022-08-19
00817302024227CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT BL661BL661BL6612022-08-19

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