FDA.reportPublic FDA data

Serum Control

Primary DI
04250317506405
Brand
Serum Control
Company
Chromsystems Instruments + Chemicals GmbH
Model
0036
Catalog number
0036
Device description
Serum Control Level I, Vitamins A and E in serum/plasma
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
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
04250317506405PackageGS15In Commercial Distribution
04250317543592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317506405042503175064054250317506405
04250317543592042503175435924250317543592

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vitamin IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of multiple vitamins 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
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
04250317555168Plasma Control Bi-Level0249-XT20249-XT22025-07-31
04250317557070Reagent 203320332025-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336235546PreciControl HIV Gen IIRoche Diagnostics GmbHJJY2026-05-22
05391523442558 Multichem CSF Plus TECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442565 Multichem CSF Plus TECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442572Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442589Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442596Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442602Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442619Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442626Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
03701700819400ELITROL IVITALSCIENTIFICJJY2026-03-04
03701700819509ELITROL IIVITALSCIENTIFICJJY2026-03-04
07333066024035EliA IgM Calibrator WellPhadia ABJJY2026-01-29
05430003908518LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908525LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908532LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908549LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908556LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908563SEEKER®Lacar MDX TechnologiesJJY2026-01-15
05051700020602EXENT® Immunoglobulin Isotypes (GAM) Control PackTHE BINDING SITE GROUP LIMITEDJJY2025-11-27
07613336216965PreciControl Phospho-Tau (181P) PlasmaRoche Diagnostics GmbHJJY2025-11-18
00884883009301MAS Omni•IMMUNE Max, Level 1Microgenics CorporationJJY2025-08-12
00884883009318MAS Omni•IMMUNE Max, Level 2Microgenics CorporationJJY2025-08-12
00884883009325MAS Omni•IMMUNE Max, Level 3Microgenics CorporationJJY2025-08-12
00884883009332MAS Omni•IMMUNE Max, Sample PackMicrogenics CorporationJJY2025-08-12
00884883009349MAS Omni•IMMUNE PRO Max, Level 1Microgenics CorporationJJY2025-08-12
00884883009356MAS Omni•IMMUNE PRO Max, Level 2Microgenics CorporationJJY2025-08-12
00884883009363MAS Omni•IMMUNE PRO Max, Level 3Microgenics CorporationJJY2025-08-12
00884883009370MAS Omni•IMMUNE PRO Max, Sample PackMicrogenics CorporationJJY2025-08-12
04250317552747Dried Blood ControlChromsystems Instruments + Chemicals GmbHJJY2025-07-31
04250317552754Dried Blood ControlChromsystems Instruments + Chemicals GmbHJJY2025-07-31