FDA.reportPublic FDA data

APO A-I

Primary DI
05055273204360
Brand
APO A-I
Company
RANDOX LABORATORIES LIMITED
Model
LP2866
Catalog number
LP2866
Device description
Intended for the quantitative in vitro determination of Apolipoprotein A-I (APO A-I) in serum and plasma
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JHNTurbidimetric Method, Lipoproteins

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHNTurbidimetric Method, LipoproteinsClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950382000APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KITRandox Laboratories, Ltd.1995-09-15JHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273204360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273204360050552732043605055273204360

GMDN Terms#

Term, Definition table
TermDefinition
Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of apolipoprotein A-I (Apo A1) lipid in a clinical specimen, using a nephelometry/turbidimetry method.

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
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
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
05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200652AMYAY7932AY79322016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055273204339APO A-IRANDOX LABORATORIES LIMITEDJHN2016-09-26
05055273204346APO BRANDOX LABORATORIES LIMITEDJHN2016-09-26
05055273204391APO A-IRANDOX LABORATORIES LIMITEDJHN2016-09-26
05055273204407APO BRANDOX LABORATORIES LIMITEDJHN2016-09-26
05055273204452APO A-IRANDOX LABORATORIES LIMITEDJHN2016-09-26
05055273204469APO BRANDOX LABORATORIES LIMITEDJHN2016-09-26
15099590010393AUBeckman Coulter, Inc.JHN2016-09-24
15099590010409AUBeckman Coulter, Inc.JHN2016-09-24
15099590080778AUBeckman Coulter, Inc.JHN2016-09-24
05051700016872Human Apolipoprotein A-1 (Apo A-1) kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDJHN2016-09-24
05051700016889Human Apolipoprotein B (Apo B) kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDJHN2016-09-24
05055273204377APO BRANDOX LABORATORIES LIMITEDJHN2016-09-16