FDA.reportPublic FDA data

SEROLOGY II POSITIVE CONTROL (SEROLOGY II CONTROL +)

Primary DI
05055273216516
Brand
SEROLOGY II POSITIVE CONTROL (SEROLOGY II CONTROL +)
Company
RANDOX LABORATORIES LIMITED
Model
SR10353
Catalog number
SR10353
Device description
Serology II Positive Control is intended for use with in vitro assays for determination of antibodies to Hepatitis B Surface Antigen (Anti HBs), IgG antibodies to Hepatitis B Core Antibodies (Anti HBc), antibodies to Hepatitis A (Anti HAV) and antibodies to Hepatitis B Envelope (Anti HBe). Serology II Positive Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay.Serology II Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
Published
2020-05-11
Public version status
Update
Distribution status
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
OHQMulti-Analyte Controls Unassayed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273216516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273216516050552732165165055273216516

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood-borne pathogen antibody/antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to, and antigens from multiple blood-borne pathogens in a clinical specimen. Pathogens detected may include (but are not limited to) human immunodeficiency virus 1 and 2 (HIV1 and HIV2), Hepatitis B virus, Hepatitis C virus, human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2), and Treponema pallidum.

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
+4494451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
Device count
1
Premarket exempt
true
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
01220000260597NATtrol™ZEPTOMETRIX CORPORATIONOHQ2026-06-04
01220000260603NATtrol™ZEPTOMETRIX CORPORATIONOHQ2026-06-04
01220000260610NATtrol™ZEPTOMETRIX CORPORATIONOHQ2026-06-04
05391523442800Multichem AE TECHNO-PATH MANUFACTURING LIMITEDOHQ2026-05-11
05391523442817Multichem AE TECHNO-PATH MANUFACTURING LIMITEDOHQ2026-05-11
05391523442824Multichem AE TECHNO-PATH MANUFACTURING LIMITEDOHQ2026-05-11
00850051429905Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
00850051429912Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
00850051429929Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
05056850400052Mimix™ Geni™ OncoMix 1 DNA/RNA FFPE Reference StandardREVVITY DISCOVERY LIMITEDOHQ2026-03-27
05056850400069Mimix™ Geni™ Negative FFPE Reference StandardREVVITY DISCOVERY LIMITEDOHQ2026-03-27
01220000260641NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2026-03-25
70845357044432QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2026-02-10
00852720008244Birlinn™ CoV2-Flu-RSV Control Panel M509MmqciOHQ2025-12-04
01220000260634NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-12-01
01220000260450NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-09-10
01220000260467NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-09-10
70845357044340QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
70845357044395QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
05056850400038Mimix™ Quantitative Multiplex FFPE reference standardREVVITY DISCOVERY LIMITEDOHQ2025-08-15
80845357044422Helix Elite Molecular StandardsMICROBIOLOGICS INC.OHQ2025-08-14
01220000260627NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-08-06
04987270235584Lumipulse Infectious Diseases ControlsFUJIREBIO INC.OHQ2025-07-31
08718734962946CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734962953CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734962960CueSee® BGEMEurotrol B.V.OHQ2025-07-25
01220000260481NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-25
08718734962991CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963004CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963011CueSee® BGEMEurotrol B.V.OHQ2025-07-25