FDA.reportPublic FDA data

Whole Blood Control

Primary DI
04250317515506
Brand
Whole Blood Control
Company
Chromsystems Instruments + Chemicals GmbH
Model
0089
Catalog number
0089
Device description
MassCheck® Immunosuppressants Whole Blood Blank Control
Published
2020-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LASDrug Specific Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LASDrug Specific Control MaterialsClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250317515506PackageGS15In Commercial Distribution
04250317544087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317515506042503175155064250317515506
04250317544087042503175440874250317544087

GMDN Terms#

Term, Definition table
TermDefinition
Multiple immunosuppressant therapeutic drug monitoring IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple immunosuppressant drugs which may include cyclosporin A (or cyclosporine), tacrolimus, sirolimus and/or everolimus, in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-18 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4989189300mailbox@chromsystems.de

Regulatory Flags#

DUNS number
328712260
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250317501554Prefilter15009150092026-01-22
04250317501578Prefilter15011150112026-01-22
04250317536204Prefilter15061150612026-01-22
04250317537577Prefilter15071150712026-01-22
04250317554611Precolumn18010180102026-01-22
04250317555281Prefilter15013150132026-01-22
04250317558022Prefilter57016570162026-01-22
04250317558084Restrictor Capillary55018550182026-01-22
04250317555137Plasma Control0250-XT20250-XT22025-07-31
04250317555151Plasma Control0251-XT20251-XT22025-07-31
04250317510174Tube48010480102025-07-31
04250317552747Dried Blood Control019501952025-07-31
04250317552754Dried Blood Control019601962025-07-31
04250317552761Dried Blood Control019701972025-07-31
04250317554819Dried Blood Control029502952025-07-31
04250317554826Dried Blood Control029602962025-07-31
04250317554833Dried Blood Control029702972025-07-31
04250317554994Plasma Calibrator Set92025-XT292025-XT22025-07-31
04250317555120Plasma Control0250-XT20250-XT22025-07-31
04250317555144Plasma Control0251-XT20251-XT22025-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B8007HMG75UFKP07-HMG 75 NG/MLUTAK LABORATORIES, INC.LAS2026-04-02
B800ACETAHIGHV2UADX0ACETAMINOPHEN PLUS HIGH V2UTAK LABORATORIES, INC.LAS2026-01-16
B800ACETALOWV2UADX0ACETAMINOPHEN PLUS LOW V2UTAK LABORATORIES, INC.LAS2026-01-16
B80044600WBF10TCH0BLANK WHOLE BLOOD 10MLUTAK LABORATORIES, INC.LAS2025-10-29
B800AED1V3SHCMC0AED LEVEL 1 V3UTAK LABORATORIES, INC.LAS2025-08-25
B8006TGRQC1UK06TGR PLUS QC LEVEL 1UTAK LABORATORIES, INC.LAS2025-08-06
B8006TGRQC2UK06TGR PLUS QC LEVEL 2UTAK LABORATORIES, INC.LAS2025-08-06
B8006TGRQC3UK06TGR PLUS QC LEVEL 3UTAK LABORATORIES, INC.LAS2025-08-06
B80088121CDFASC0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2025-03-24
B80091801UAL0BUPRENORPHINE HYDROLYSIS QCUTAK LABORATORIES, INC.LAS2025-01-13
B80088121CDFL500NPM0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-12-20
B80044600WBF100MLRH0BLANK WHOLE BLOOD 100MLUTAK LABORATORIES, INC.LAS2024-12-11
B80090000UFLTI0NICOTINE PLUS LEVEL 1UTAK LABORATORIES, INC.LAS2024-09-30
B80090001UFLTI0NICOTINE PLUS LEVEL 2UTAK LABORATORIES, INC.LAS2024-09-30
B80088121CDFF10NJSP0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-09-18
B80088121CDFL50PML0CERTIFIED DRUG FREE URINE UTAK LABORATORIES, INC.LAS2024-09-05
B80011511050SMXHFAH0BLANK HAIR MATRIXUTAK LABORATORIES, INC.LAS2024-08-23
B800AEDSSCH0AED PLUSUTAK LABORATORIES, INC.LAS2024-07-17
B80044600WBFPOSAFT0POSITIVE WHOLE BLOODUTAK LABORATORIES, INC.LAS2024-05-20
B80088121CDFF10FS0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-05-06
B8007AMINOHIGHUPM07-AMINOCLONAZEPAM HIGHUTAK LABORATORIES, INC.LAS2024-05-03
B8007AMINOLOWUPM07-AMINOCLONAZEPAM LOWUTAK LABORATORIES, INC.LAS2024-05-03
B80088121CDFF100PDH0CERTIFIED DRUG FREE URINE 100MLUTAK LABORATORIES, INC.LAS2024-04-30
B80066815V3HRLC0HIGH RANGE TRACE ELEMENTS V3UTAK LABORATORIES, INC.LAS2024-04-03
B80066816V3NRLC0NORMAL RANGE TRACE ELEMENTS V3UTAK LABORATORIES, INC.LAS2024-04-03
B800ACETAUV4PM0ACETAMINOPHEN PLUS V4UTAK LABORATORIES, INC.LAS2024-03-12
B80092021IDC0SSRI 12 LEVEL 2UTAK LABORATORIES, INC.LAS2024-03-06
B800ACE250SFBSRHS0ACETONE 250 MG/DLUTAK LABORATORIES, INC.LAS2024-02-27
B80088121CDFLLTRWVDTL0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-02-20
B800ACIDNEUTQC0ACID-NEUT QCUTAK LABORATORIES, INC.LAS2024-02-16