FDA.reportPublic FDA data

CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214

Primary DI
00817302020229
Brand
CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
CC214
Catalog number
CC214
Device description
ALB (Albumin) BCP 2 x 300 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CJWBROMCRESOL PURPLE DYE-BINDING, ALBUMIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJWBromcresol Purple Dye-Binding, AlbuminClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817302020229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302020229008173020202298173020202290817302020229

GMDN Terms#

Term, Definition table
TermDefinition
Albumin IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of albumin in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume101Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00After opening, the reagent is stable for 30 days on board a clinical analyzer
Special Storage Condition, Specify00Unopened Reagent is stable until expiration date on kit when stored at 8 to 30°
Storage Environment Temperature8 Degrees Celsius30 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
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817302020182CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT BL-224BL-224.BL-224.2016-09-01
00817302020199CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 ALBUMIN REAGENT KIT Product No. ST224ST224ST2242016-09-01
00817302020205CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT. KIT AU-224AU-224AU-2242016-09-01
00817302020212CAROLINA LIQUID CHEMISTRIES CORP.® ALB (BCG) CC224CC224CC2242016-09-01
00817302020946CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214AU-214AU-2142016-09-01
00817302022957CAROLINA LIQUID CHEMISTRIES CORP.® ALB REAGENT PRODUCT NO. DT224DT224DT2242016-10-17
00817302021912CAROLINA LIQUID CHEMISTRIES CORP.® OXYC RGT. KIT BL-419BBL419BBL419B2016-09-01
00817302020786CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT BL-425BL425BL4252016-09-01
00817302020809CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT AU-425AU-425AU-4252016-09-01
00817302020816CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM REAGENT KIT Product No. DT425DT425DT4252016-09-01
00817302020847CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT AU-424AU-424AU-4242016-09-01
00817302021066CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT AU-412AU-412AU-4122016-09-01
00817302021127CAROLINA LIQUID CHEMISTRIES CORP.® BARB RGT. KIT AU-417AU-417AU-4172016-09-01
00817302021189CAROLINA LIQUID CHEMISTRIES CORP.® BENZ RGT. KIT AU-418AU-418AU-4182016-09-01
00817302021257CAROLINA LIQUID CHEMISTRIES CORP.® COCM RGT. KIT AU-413AU-413AU-4132016-09-01
00817302021349CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421BL421BL4212016-09-01
00817302021370CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421AU-421AU-4212016-09-01
00817302021455CAROLINA LIQUID CHEMISTRIES CORP.® METD RGT. KIT AU-415AU-415AU-4152016-09-01
00817302021516CAROLINA LIQUID CHEMISTRIES CORP.® METH RGT. KIT AU-427AU-427AU-4272016-09-01
00817302021523CAROLINA LIQUID CHEMISTRIES CORP.® METH RGT. KIT Product No. DT427DT427DT4272016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654003Atellica CH AlbPSiemens Healthcare Diagnostics Inc.CJW2026-03-18
00380740155285AlinityABBOTT IRELANDCJW2024-08-15
00380740155292AlinityABBOTT IRELANDCJW2024-08-15
00380740155483ARCHITECTABBOTT IRELANDCJW2024-08-15
00380740155490ARCHITECTABBOTT IRELANDCJW2024-08-15
08058056681973Albumin BCP (6x20 mL)SENTINEL CH. SPACJW2020-02-24
08058056681980Albumin BCP (6x50 mL)SENTINEL CH. SPACJW2020-02-24
00380740121723AlinityAbbott GmbHCJW2018-07-11
00630414595825Atellica CH AlbPSiemens Healthcare Diagnostics Inc.CJW2017-12-22
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00842768015021Dimension Vista® Flex® reagent cartridge ALBSiemens Healthcare Diagnostics Inc.CJW2016-09-24
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00630414947419ADVIA® Chemistry Albumin BCP ReagentsSiemens Healthcare Diagnostics Inc.CJW2016-09-24
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EABA40000411Piccolo AmLyte 13ABAXIS, INC.CJW2016-09-23
04015630928064Albumin BCPRoche Diagnostics GmbHCJW2016-09-20
04015630990634AlbuminBCP AlbuminBCPRoche Diagnostics GmbHCJW2016-09-20
00851445007006GENCHEM™ Albumin ReagentGENCHEM INCCJW2016-09-19
05055273200034ALBRANDOX LABORATORIES LIMITEDCJW2016-09-16
00817302020946CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214CAROLINA LIQUID CHEMISTRIES CORPORATIONCJW2016-09-01
15099590233341SynchronBeckman Coulter, Inc.CJW2016-08-24
15099590625719SynchronBeckman Coulter, Inc.CJW2016-08-24
00380740012816ARCHITECTABBOTT LABORATORIESCJW2016-06-06