FDA.reportPublic FDA data

Liposure Serum Lipoprotein Control Level 1 4x0.5mL

Primary DI
00896863002318
Brand
Liposure Serum Lipoprotein Control Level 1 4x0.5mL
Company
QUANTIMETRIX CORPORATION
Model
48-7060
Catalog number
48-7060
Device description
The Liposure Lipoprotein Control is intended for monitoring lipoprotein fractions (VLDL to HDL) as well as subfractions (Mid-bands, LDL subfractions 1, 2, and 3) using the Lipoprint LDL System to validate the separation and quantitation of lipoproteins in patient serum samples. It is prepared from human serum and supplied lyophilized. The lyophilized material contains stabilizers and preservatives.
Published
2018-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JHOElectrophoretic Separation, Lipoproteins
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHOElectrophoretic Separation, LipoproteinsClinical Chemistry1
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010337000
K013662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010337000LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix Corp.2001-07-25JHO
K013662000MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix Corp.2002-03-08JHO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896863002318PrimaryGS10
M05148706019SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896863002318008968630023188968630023180896863002318

GMDN Terms#

Term, Definition table
TermDefinition
Total lipoprotein IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total lipoprotein lipid in a clinical specimen.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
(310) 536-0006sales@quantimetrix.com

Regulatory Flags#

DUNS number
010717890
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
00896863002424Chromascopics Control Level 1&2 Set 2x25mL (International)1540-031540-032023-05-04
00896863002356QuanTtest Human Protein Standards Set3410-023410-022021-09-10
00896863002004Dropper Spinal Fluid Control Level 1 Set 3x3mL1451-311451-312018-09-26
00896863002011Dropper Spinal Fluid Control Level 2 Set 3x3mL1452-311452-312018-09-26
00896863002073Dropper Spinal Fluid Control Level 1&2 Set 2x3mL1450-011450-012018-09-26
00896863002042Chromascopics Control Level 1&2 Set 4x120mL (Domestic)1540-021540-022018-09-26
00896863002066Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL1510-021510-022018-09-26
00896863002349QuanTtest Red Pyrogallol Red Reagent5210-125210-122019-09-27
00896863002394Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL1470-021470-022019-03-13
00896863002028Sweat Control Level 1, 2, & 3 Set 9x3mL1190-011190-012018-09-26
00896863002035Chromascopics Control Level 1&2 Set 4x120mL (International)1540-011540-012018-09-26
00896863002059Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL1290-011290-012018-09-26
00896863002080Spinalscopics Control Level 1 Set 3x3mL1461-311461-312018-09-26
00896863002097Spinalscopics Control Level 2 Set 3x3mL1462-311462-312018-09-26
00896863002103Microbumin Microalbumin Control Level 1&2 Set 10x7mL1250-011250-012018-09-26
00896863002110Dropper Urinalysis Dipstick Control Level 1&2 Set 4x25mL1440-021440-022018-09-26
00896863002127Dropper Urinalysis Dipstick Control Level 1&2 Set 2x25mL1440-031440-032018-09-26
00896863002134Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL1440-011440-012018-09-26
00896863002141Dipper Urinalysis Dipstick Control Level 2 Set 6x15mL1442-611442-612018-09-26
00896863002158Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 10x5mL1440-041440-042018-09-26

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