Urine Calibrator Set 75228

GUDID 04250317551115

3PLUS1® Multilevel Urine Calibrator Set MassChrom® Amino Acid Analysis in urine

Chromsystems Instruments + Chemicals GmbH

Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator Multiple amino acid IVD, calibrator
Primary Device ID04250317551115
NIH Device Record Key80b214bf-af57-44b0-9c98-1b48e18f64e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrine Calibrator Set
Version Model Number75228
Catalog Number75228
Company DUNS328712260
Company NameChromsystems Instruments + Chemicals GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de

Device Dimensions

Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0
Total Volume0.5 Milliliter
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104250317551115 [Primary]

FDA Product Code

JIXCalibrator, Multi-Analyte Mixture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-18
Device Publish Date2022-07-08

On-Brand Devices [Urine Calibrator Set]

042503175392436PLUS1® Multilevel Urine Calibrator Set MassChrom® Total Metanephrines
042503175377066PLUS1® Multilevel Urine Calibrator Set MassChrom® VMA, HVA, 5-HIAA
042503175367546PLUS1® Multilevel Urine Calibrator Set MassChrom® Ethyl Glucuronide, Ethyl Sulfate
042503175258573PLUS1® Multilevel Urine Calibrator Set MassChrom® Methylmalonic Acid
042503175377996PLUS1® Multilevel Urine Calibrator Set MassChrom® Catecholamines, free Metanephrines, Seroton
042503175423426PLUS1® Multilevel Urine Calibrator Set MassTox® Drugs of Abuse Testing in urine
042503175511153PLUS1® Multilevel Urine Calibrator Set MassChrom® Amino Acid Analysis in urine

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.