FDA.reportPublic FDA data

Calibrator for Lucica® Glycated Albumin-L

Primary DI
04987153301054
Brand
Calibrator for Lucica® Glycated Albumin-L
Company
ASAHI KASEI PHARMA CORPORATION
Model
G252GA
Catalog number
G252GA
Device description
Calibrator L (1 mL × 1), Calibrator H (1 mL × 1)
Published
2019-02-22
Public version status
Update
Distribution status
Not 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
JITCalibrator, secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987153301054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987153301054049871533010544987153301054

GMDN Terms#

Term, Definition table
TermDefinition
Glycated albumin IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of glycated albumin in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+18005315535techsupport@ekfdiagnostics.com

Regulatory Flags#

DUNS number
700853096
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987153301016Lucica® Glycated Albumin-L GA R-1L212GAL212GA2019-02-22
04987153301023Lucica® Glycated Albumin-L GA R-2L222GAL222GA2019-02-22
04987153301030Lucica® Glycated Albumin-L ALB R-1L232GAL232GA2019-02-22
04987153301047Lucica® Glycated Albumin-L ALB R-2L242GAL242GA2019-02-22
04987153301061Control for Lucica® Glycated Albumin-LG282GAG282GA2019-02-22

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