FDA.reportPublic FDA data

Reagent

Primary DI
04250317508744
Brand
Reagent
Company
Chromsystems Instruments + Chemicals GmbH
Model
44001
Catalog number
44001
Device description
Mobile Phase A, Porphyrins in urine
Published
2020-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JKJFluorometric Measurement, Porphyrins

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKJFluorometric Measurement, PorphyrinsClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250317508744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317508744042503175087444250317508744

GMDN Terms#

Term, Definition table
TermDefinition
Total porphyrin (coproporphyrin/uroporphyrin) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total porphyrin (coproporphyrin/uroporphyrin) 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 Temperature18 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
328712260
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250317537591Reagent80610806102020-08-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250317508713Reagent KitChromsystems Instruments + Chemicals GmbHJKJ2020-08-27
04250317508768ReagentChromsystems Instruments + Chemicals GmbHJKJ2020-08-27
04250317508805ReagentChromsystems Instruments + Chemicals GmbHJKJ2020-08-27
04250317508829ReagentChromsystems Instruments + Chemicals GmbHJKJ2020-08-27
04250317508843ReagentChromsystems Instruments + Chemicals GmbHJKJ2020-08-27
M52520010ProtoFluor Glass SlidesHELENA LABORATORIES CORPORATIONJKJ2017-03-17
M52520020ProtoFluor Reagent (2x15 mL)HELENA LABORATORIES CORPORATIONJKJ2017-03-17
M52520100ProtoFluor Calibrator - Low (5 x 2.5 mL)HELENA LABORATORIES CORPORATIONJKJ2017-03-17
M52520110ProtoFluor Calibrator - High (5 x 2.5 mL)HELENA LABORATORIES CORPORATIONJKJ2017-03-17
M5255510560ProtoFluor Reagent System (Part 1 of 2)HELENA LABORATORIES CORPORATIONJKJ2017-03-17
M5255510570ProtoFluor Reagent System (Part 2 of 2)HELENA LABORATORIES CORPORATIONJKJ2017-03-17
M52520050000ProtoFluor Z (110V)HELENA LABORATORIES CORPORATIONJKJ2017-03-17
M52520050020ProtoFluor Z (110V)HELENA LABORATORIES CORPORATIONJKJ2017-03-17
M52520060000ProtoFluor Z (220V)HELENA LABORATORIES CORPORATIONJKJ2017-03-17