FDA.reportPublic FDA data

Sirrus® Albumin LiquiColor®

Primary DI
00657498001516
Brand
Sirrus® Albumin LiquiColor®
Company
STANBIO LABORATORY, L.P.
Model
S0285-750
Catalog number
S0285-750
Device description
For the quantitative determination of albumin in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DCFAlbumin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DCFAlbumin, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00657498001516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498001516006574980015166574980015160657498001516

GMDN Terms#

Term, Definition table
TermDefinition
Albumin IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of albumin in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
045361136
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00657498001950Procalcitonin LiquiColor2300-0602300-0602017-06-26
00657498000434Albumin LiquiColor®0285-5000285-5002016-09-23
00657498000847Glycated Serum Protein (GSP) LiquiColor®2350-0622350-0622016-09-23
00657498002179STAT-Site WB Dual Analyte Measurement System7000-0017000-0012019-11-18
00657498002193STAT-Site WB Blood Glucose Test Strips7010-0257010-0252019-11-18
00657498002209STAT-Site WB Blood Glucose Test Strips7010-0507010-0502019-11-18
00657498002216STAT-Site WB Blood Glucose Test Strips7010-1007010-1002019-11-18
00657498002230STAT-Site WB B-Ketone Test Strips7020-0257020-0252019-11-18
00657498002247STAT-Site WB B-Ketone Test Strips7020-0507020-0502019-11-18
00657498002254STAT-Site WB B-Ketone Test Strips7020-1007020-1002019-11-18
00657498002261Blood Glucose Control Solution7014-2047014-2042019-11-18
00657498002278B-Ketone Control Solution7024-2047024-2042019-11-18
00657498000427Acetaminophen Liquicolor®2400-0602400-0602016-09-23
00657498000441Alkaline Phosphatase LiquiColor®2900-4302900-4302016-09-23
00657498000458Alkaline Phosphatase LiquiColor®2900-5002900-5002016-09-23
00657498000489a-Amylase LiquiColor®2970-4302970-4302016-09-23
00657498000496AST/SGOT Liqui-UV®2920-4302920-4302016-09-23
00657498000502AST/SGOT Liqui-UV®2920-5002920-5002016-09-23
00657498000519B-Hydroxybutyrate LiquiColor®2440-0582440-0582016-09-23
00657498000526Synchron® CX/LX/DX B-Hydroxybutyrate LiquiColor®B2440-180B2440-1802016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414611099Atellica CH Urine Albumin (UAlb)Siemens Healthcare Diagnostics Inc.DCF2025-08-11
00630414320298Atellica CH Urine Albumin (UAlb)Siemens Healthcare Diagnostics Inc.DCF2025-08-11
04050598163300Albumin ELISAImmundiagnostik AGDCF2023-06-21
03610230007235Yumizen C1200 Albumin U/CSFHORIBA ABX SASDCF2020-09-14
00628063401116MicroalbuminSEKISUI DIAGNOSTICS, LLCDCF2019-10-02
06970291985222Microalbuminuria Kit (Immunoturbidimetric Method)Medicalsystem Biotechnology Co., Ltd.DCF2019-03-07
00386100002213UALB Reagent KitMEDICA CORPORATIONDCF2019-02-14
00817274022788JAS DiagnosticsDREW SCIENTIFIC, INC.DCF2018-07-24
00817274022795JAS DiagnosticsDREW SCIENTIFIC, INC.DCF2018-07-24
B24224MABHUE010Microalbumin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.DCF2018-01-16
03610230008232ABX Pentra Micro ALB 2 CalHORIBA ABX SASDCF2017-07-07
03610230008225ABX Pentra Micro ALBUMIN 2 CPHORIBA ABX SASDCF2017-06-27
05051700018432Optilite Low Level Albumin KitTHE BINDING SITE GROUP LIMITEDDCF2017-06-07
15099590010645AUBECKMAN COULTER IRELAND INC.DCF2016-09-24
15099590020422AUBeckman Coulter, Inc.DCF2016-09-24
15099590670108AUBeckman Coulter, Inc.DCF2016-09-24
B1761140Antiserum to Human AlbuminKENT LABORATORIES INCDCF2016-09-24
05051700010689Human Albumin NL BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDDCF2016-09-24
05051700016193Human Albumin CSF Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDCF2016-09-24
05051700017916Optilite Albumin KitTHE BINDING SITE GROUP LIMITEDDCF2016-09-24
05051700017923Human Microalbumin Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDCF2016-09-24
00842768005312Dimension® Flex® reagent cartridge MALBSiemens Healthcare Diagnostics Inc.DCF2016-09-24
00842768006098DImension Vista® sALB Flex® reagent cartridgeSpecialty AlbuminSiemens Healthcare Diagnostics Products GmbHDCF2016-09-24
00842768006203DImension Vista® Microalbumin Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDCF2016-09-24
00842768038013N Antiserum to Human AlbuminSiemens Healthcare Diagnostics Products GmbHDCF2016-09-24
00842768038020N Antiserum to Human AlbuminSiemens Healthcare Diagnostics Products GmbHDCF2016-09-24
00657498000434Albumin LiquiColor®STANBIO LABORATORY, L.P.DCF2016-09-23
04015630924899Tinaquant Albumin Gen2Roche Diagnostics GmbHDCF2016-09-20
00628063400812MICROALBUMIN AssaySEKISUI DIAGNOSTICS, LLCDCF2016-09-20
00816426020139K-ASSAY® Microalbumin ReagentKAMIYA BIOMEDICAL COMPANY, LLCDCF2016-09-16