FDA.report

HDL Ultra Calibrator Kit

Primary DI
00628063400577
Brand
HDL Ultra Calibrator Kit
Company
SEKISUI DIAGNOSTICS, LLC
Model
6272-3
Catalog number
6272-3
Published
2016-09-16
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

Related Records

Product Codes

CodeName
JISCALIBRATOR, PRIMARY

Product Code Classifications

CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00628063400577PrimaryGS10
10628063400574Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400577006280634005776280634005770628063400577
1062806340057410628063400574

GMDN Terms

TermDefinition
High-density lipoprotein (HDL) cholesterol IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of high-density lipoprotein (HDL) cholesterol lipid in a clinical specimen.

Sterilization Methods

Method

Regulatory Flags

DUNS number
966812344
Device count
3
DM exempt
false
Premarket exempt
false
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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