FDA.reportPublic FDA data

EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA U60)

Primary DI
05055273219999
Brand
EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA U60)
Company
RANDOX LABORATORIES LIMITED
Model
SCK10689
Catalog number
SCK10689
Device description
The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebotomist. The samples will be transported to a professional laboratory for testing.
Published
2024-01-30
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
05055273219999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273219999050552732199995055273219999

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 Humidity15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 304 728 2890customersupportusa@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
00810111410038LetsGetChecked Blood Sample Collection Kit (LIPP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
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