FDA.reportPublic FDA data

Accessorie

Primary DI
04250317547484
Brand
Accessorie
Company
Chromsystems Instruments + Chemicals GmbH
Model
65758
Catalog number
65758
Device description
Collection Plates for automated sample preparation, Vitamin C in plasma/serum
Published
2020-08-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250317547484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317547484042503175474844250317547484

GMDN Terms#

Term, Definition table
TermDefinition
Microplate IVDA plate with multiple wells designed to contain small volumes of clinical specimens, reagents, or other materials for testing procedures performed by a laboratory analyser. It is typically made of sterilizable plastic material (e.g., polypropylene) and is used with manual or automated analysers. This is a single-use device.

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
+498918930mailbox@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
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JMA2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JMA2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JMA2026-04-16
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JMA2025-09-18
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JMA2024-06-14
08806141303497One+Step 10ADFI CO.,LTDJMA2023-10-16
00840239048882Vitamin C (Ascorbic Acid)DRG International IncJMA2023-09-01
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JMA2023-06-08
10884389181973MedlineMEDLINE INDUSTRIES, INC.JMA2022-04-13
10884389181959MedlineMEDLINE INDUSTRIES, INC.JMA2021-09-16
00722066005255Rapid ResponseBTNX IncJMA2020-12-14
04250317513854ReagentChromsystems Instruments + Chemicals GmbHJMA2020-08-27
04250317535801ReagentChromsystems Instruments + Chemicals GmbHJMA2020-08-27
04250317535979Reagent KitChromsystems Instruments + Chemicals GmbHJMA2020-08-27
04250317547460Reagent KitChromsystems Instruments + Chemicals GmbHJMA2020-08-27
04250317547477AccessorieChromsystems Instruments + Chemicals GmbHJMA2020-08-27
04250317547491AccessorieChromsystems Instruments + Chemicals GmbHJMA2020-08-27
10888277110403MedlineMEDLINE INDUSTRIES, INC.JMA2020-08-21
10885380175589CARDINAL HEALTHCardinal Health 200, LLCJMA2020-07-09