FDA.reportPublic FDA data

POINTE SCIENTIFIC Cholesterol Standard

Primary DI
00811727010858
Brand
POINTE SCIENTIFIC Cholesterol Standard
Company
POINTE SCIENTIFIC, INC.
Model
C7509-STD
Catalog number
C7509-STD
Device description
Intended for use as an cholesterol standard for standardization or calibration of enzymatic, endpoint cholesterol procedures.
Published
2016-08-31
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
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
00811727010858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727010858008117270108588117270108580811727010858

GMDN Terms#

Term, Definition table
TermDefinition
Total cholesterol lipid IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of total cholesterol lipid in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-445-9853techservice@medtest.com

Regulatory Flags#

DUNS number
045623154
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
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

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00811727015730Pointe AST on the BS480 Analyzer14-A7561-37514-A7561-3752020-05-28
00811727015754Pointe Calcium Arsenazo for BS48014-C7529-36014-C7529-3602020-05-28
00811727015778Pointe Cholesterol on BS48014-C7510-48014-C7510-4802020-05-28
00811727015792Pointe Carbon Dioxide on the BS48014-C7502-16014-C7502-1602020-05-28
00811727015839Pointe GGT on BS48014-G7571-20014-G7571-2002020-05-28
00811727015846Pointe Glucose Hexokinase for BS48014-G7517-48014-G7517-4802020-05-28
00811727015860Pointe autoHDL for the BS48014-H7545-30014-H7545-4002020-05-28
00811727015877Pointe Homocysteine for BS48014-H7575-14414-H7575-1442020-05-28
00811727015884Pointe Total Iron for the BS48014-HI904-35014-HI904-3502020-05-28
00811727015693Pointe Albumin on BS480 Analyzer14-A7502-48014-A7502-4802020-05-28
00811727018632Pointe Scientific CK-MBC7563-30C7563-302021-02-28
00811727018649Pointe Scientific CK-MBC7563-90C7563-902021-02-28
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00811727015594Pointe Lipoprotein (a) Control SetL7597-CTLL7597-CTL2021-01-30
00811727015679Pointe G6PD ControlsG7583-CTLG7583-CTL2021-01-30
00811727015815Pointe CRP Reagent14-C7568-48014-C7568-4802021-01-30
00811727015891Pointe Lactate Reagent 14-L7596-38014-L7596-3802021-01-30
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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