FDA.reportPublic FDA data

VK-CREA

Primary DI
00860003561966
Brand
VK-CREA
Company
RADIOMETER AMERICA INC.
Model
VK-CREA
Device description
Kit of QC material for the validation of sensor linear response in ABL8X7 series
Published
2020-09-25
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
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003561966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003561966008600035619668600035619660860003561966

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
8007360600support@radiometeramerica.com

Regulatory Flags#

DUNS number
086661485
Device count
1
Kit
true
Combination product
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
01860003561903safePICO616-KIT Box of 1002020-09-25
01860003561927safePICO623-KIT Box of 1002020-09-25
10860003561901Safe PICO Kit616-KIT Box of 1002021-02-17
10860003561925Safe PICO Kit623-KIT Box of 1002021-02-17
00860003561904Safe PICO Kit616-KIT2020-09-25
00860003561928safePICO623-KIT2020-09-25
00860003561942VKR-5VKR-52020-09-25
00860003561959VKR-7VKR-72020-09-25
00860003561935VK-3VK-32020-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700699445193S7620 QUALICHECK 7+, level 0 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
05700699445209S7630 QUALICHECK 7+, level 1 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
05700699445216S7640 QUALICHECK 7+, level 2 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
05700699445223S7650 QUALICHECK 7+, level 3 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
05700699445230S7660 QUALICHECK 7+, level 4 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
00850010224497CareSuperb COVID-19 Antigen External ControlAccess Bio Inc.JJY2026-10-01
10673486014112Teco Diagnostics TC-TROL (N) Serum Control Level I HumanTECO DIAGNOSTICSJJY2026-08-25
10673486014129Teco Diagnostics TC-TROL (A) Serum Control Level II HumanTECO DIAGNOSTICSJJY2026-08-25
00850011135556VALIDATELgc Clinical Diagnostics, Inc.JJY2026-07-07
00850011135853ValidateLgc Clinical Diagnostics, Inc.JJY2026-07-07
00850010224459CareSuperb COVID-19/Flu A&B Antigen Combo External ControlAccess Bio Inc.JJY2026-06-08
05391523442831Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442848Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442855Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442862Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442879Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442886Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442893Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442909Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442916Multichem NBTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442923Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442930Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
00884883009080MAS Immunology Advanced Sample PackMicrogenics CorporationJJY2026-05-27
00884883011373MAS Immunology Advanced Level 1Microgenics CorporationJJY2026-05-27
00884883011380MAS Immunology Advanced Level 2Microgenics CorporationJJY2026-05-27
00884883011397MAS Immunology Advanced Level 3Microgenics CorporationJJY2026-05-27
00884883011427CRP (C-Reactive Protein)Microgenics CorporationJJY2026-05-27
00850028489048TriVerity Level 1 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489055TriVerity Level 2 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489093TriVerity Verification PanelInflammatix, Inc.JJY2026-04-30