FDA.reportPublic FDA data

ConcizuTrace™ Sample Collection Kit

Primary DI
05055273218893
Brand
ConcizuTrace™ Sample Collection Kit
Company
RANDOX LABORATORIES LIMITED
Model
CZM10596
Catalog number
CZM10596
Device description
The Randox ConcizuTrace™ sample collection kit is used for the collection and transportation of blood samples, taken by a trained phlebotomist. The samples will be transported to a professional laboratory for testing using either the ConcizuTrace™ ELISA kit or Concizumab ELISA kit.
Published
2023-07-31
Public version status
New
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
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)Clinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273218893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273218893050552732188935055273218893

GMDN Terms#

Term, Definition table
TermDefinition
Venous blood collection kit IVDA collection of in vitro diagnostic devices and materials intended for use by a healthcare professional at the point-of-care for the collection of a venous blood specimen, for subsequent diagnostic testing or screening. The kit typically includes venous access needle with tubing and connector, a blood collection tube(s) [with or without additives (e.g., sodium citrate)], and additional items (e.g., tourniquet, pipette, gauze pads, alcohol pads, dressings and a container with a requisition form, for mailing to the laboratory). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442894451070concizutrace.support@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
04779054721273RDA SpotRDA SPOT, UABPQD2026-08-14
04779054721549PulsettoRDA SPOT, UABPQD2026-08-14
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00810111410052LetsGetChecked Blood Sample Collection Kit (HCV)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410182LetsGetChecked Blood Sample Collection Kit (MHTP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410199LetsGetChecked Blood and Saliva Sample Collection Kit (MHTPC)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410205LetsGetChecked Blood Sample Collection Kit (MHTP)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410250LetsGetChecked Blood Sample Collection Kit (ANMH2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410366LetsGetChecked Blood Sample Collection Kit (TRFNUS+)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410540LetsGetChecked Blood Sample Collection Kit (GLCS)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410557LetsGetChecked Blood Sample Collection Kit (LEAD)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410588LetsGetChecked Blood Sample Collection Kit (HPSP)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410649LetsGetChecked Blood Sample Collection Kit (OBIOMVA & OBIOMV)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410694LetsGetChecked Blood Sample Collection Kit (EWB1)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410700LetsGetChecked Blood Sample Collection Kit (EDB1)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410793LetsGetChecked Blood Sample Collection Kit (KDRN)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410816LetsGetChecked Blood Sample Collection Kit (CDST1)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410908LetsGetChecked Blood and Saliva Sample Collection Kit (PCOS3)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00850024881877LetsGetChecked Blood Sample Collection Kit (BIOM)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00850024881884LetsGetChecked Blood Sample Collection Kit (BIOM4)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00850024881952LetsGetChecked Blood Sample Collection Kit (GLCSLIPP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00850038691172Tasso+ Standard KitTasso Inc.PQD2026-07-06
00850038691189Tasso Mini Standard KitTasso Inc.PQD2026-07-06
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220803BASELINE Venous Sample Collection kitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
00850024881860LetsGetChecked Blood Sample Collection Kit (BIOM2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-05-06
00810010895011Aero-MedAERO-MED, LLCPQD2026-05-04