FDA.reportPublic FDA data

AU

Primary DI
15099590010140
Brand
AU
Company
Beckman Coulter, Inc.
Model
OSR6116
Device description
Cholesterol
Published
2016-09-24
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
true

Product Codes#

Code, Name table
CodeName
CHHEnzymatic Esterase--Oxidase, Cholesterol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHHEnzymatic Esterase--Oxidase, CholesterolClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590010140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959001014015099590010140

GMDN Terms#

Term, Definition table
TermDefinition
Total cholesterol lipid IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total cholesterol lipid in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16
15099590806422ACCESS anti-HAV CALIBRATORD258322026-01-16
15099590806439ACCESS anti-HAV QCD258332026-01-16
15099590799717MicroScanV5.03D238242025-12-17
15099590799724MicroScanV5.03D238252025-12-17
15099590799755MicroScanV5.03D238282025-12-17
15099590799762MicroScanV5.03D238292025-12-17
05099590798973MicroScanD18443D184432025-12-08
05099590798980MicroScanD18444D184442025-12-08
05099590798997MicroScanD184452025-12-08
05099590799000MicroScanD184462025-12-08
05099590799017MicroScanD184472025-12-08
05099590799024MicroScanD184482025-12-08
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10682607690098Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.CHH2026-03-09
10381934770014CholesterolPOLYMER TECHNOLOGY SYSTEMS, INC.CHH2025-06-16
00380740158125AlinityABBOTT IRELANDCHH2025-04-15
00380740158132ARCHITECTABBOTT IRELANDCHH2025-04-15
00380740158149ARCHITECTABBOTT IRELANDCHH2025-04-15
80816042015201FORAFORA CARE INC.CHH2025-03-14
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.CHH2024-07-12
08806141303701Newfoundland Cholesterol TestDFI CO.,LTDCHH2024-05-29
00893038002883Cholestech LDX™ALERE SAN DIEGO, INC.CHH2023-12-20
00893038002890Cholestech LDX™ALERE SAN DIEGO, INC.CHH2023-12-20
00893038002906Cholestech LDX™ALERE SAN DIEGO, INC.CHH2023-12-20
00816042014482FORAFORA CARE INC.CHH2023-10-31
10673486001419Teco Diagnostics Cholesterol TC-Matrix-240TECO DIAGNOSTICSCHH2023-08-01
10673486001426Teco Diagnostics Cholesterol TC-Matrix-480TECO DIAGNOSTICSCHH2023-08-01
06936895301882BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHH2023-07-26
06936895301899BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHH2023-07-26
06936895301905BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHH2023-07-26
06936895301912BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHH2023-07-26
10673486001457Teco Diagnostics Cholesterol Reagent SetTECO DIAGNOSTICSCHH2023-07-26
10673486001464Teco Diagnostics Cholesterol Reagent SetTECO DIAGNOSTICSCHH2023-07-26
10673486001471Teco Diagnostics Cholesterol Reagent SetTECO DIAGNOSTICSCHH2023-07-26
10673486001402Teco Diagnostics Cholesterol (Liquid) Reagent SetTECO DIAGNOSTICSCHH2023-07-25
10673486001433Teco Diagnostics Cholesterol (Liquid) Reagent SetTECO DIAGNOSTICSCHH2023-07-25
10673486001440Teco Diagnostics Cholesterol TC MatrixTECO DIAGNOSTICSCHH2023-07-25
00816042014079FORAFORA CARE INC.CHH2023-06-26
80816042014174FORAFORA CARE INC.CHH2023-06-26
80816042014860FORAFORA CARE INC.CHH2023-06-26
00816042014161FORAFORA CARE INC.CHH2023-06-16
00887473000320STANDARD™ LipidoCare AnalyzerSD Biosensor, Inc.CHH2023-04-07
00887473000283STANDARD™ LipidoCare AnalyzerSD Biosensor, Inc.CHH2023-03-17