Precolumn Cartridge 17046

GUDID 04250317502506

Precolum Cartridge 4/10, Mycophenolic Acid in plasma/serum

Chromsystems Instruments + Chemicals GmbH

High performance liquid chromatography analyser column IVD

• Primary Device ID: 04250317502506
• NIH Device Record Key: 73863e4c-8ad5-4570-b7fc-aef45d5a2cba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precolumn Cartridge
• Version Model Number: 17046
• Catalog Number: 17046
• Company DUNS: 328712260
• Company Name: Chromsystems Instruments + Chemicals GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250317502506 [Primary]

FDA Product Code

• KZR: Chromatography (Liquid, Gel), Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-04
• Device Publish Date: 2020-08-27

On-Brand Devices [Precolumn Cartridge]

• 04250317547262: Precolum Cartridge 4/10, Antibiotics in serum/plasma
• 04250317538628: Precolum Cartridge 4/10, 1-Hydroxypyrene in urine
• 04250317532039: UHPLC Precolum Cartridge 4/10, Vitamins A and E in serum/plasma
• 04250317520074: Precolum Cartridge 4/10, Coenzyme Q10 in serum/plasma/whole blood
• 04250317520067: Precolum Cartridge 4/10, Malondialdehyde in plasma/serum
• 04250317520050: Precolum Cartridge 4/10, Glutathione in whole blood
• 04250317520043: Precolum Cartridge 4/10, Vitamin C in plasma/serum
• 04250317520012: Precolum Cartridge 4/10, Vitamin B1 in whole blood, Vitamin B6 in whole blood/plasma
• 04250317520005: Precolum Cartridge 4/10, 5-HIAA in urine
• 04250317519986: Precolum Cartridge 4/10, Crosslinks in urine
• 04250317519979: Precolum Cartridge 4/10, t,t-Muconic Acid in urine
• 04250317519948: Precolum Cartridge 4/10, Porphyrins in urine
• 04250317519931: Precolum Cartridge 4/10, Hippuric Acid, Methylhippuric Acids, Mandelic acid, Phenylglyoxylic Aci
• 04250317519924: Precolum Cartridge 4/10, o-Cresol, p-Cresol, Phenol in urine
• 04250317519917: Precolum Cartridge 4/10, 25-OH-Vitamin D3/D2 in serum/plasma
• 04250317519887: Precolum Cartridge 4/10, Vitamin B1 in whole blood
• 04250317519870: Precolum Cartridge 4/10, Vitamins A and E in serum/plasma
• 04250317519863: Precolum Cartridge 4/10, ß-Carotene in serum/plasma
• 04250317519856: Precolum Cartridge 4/10, Vitamin B6 in plasma/serum/whole blood
• 04250317519825: Precolum Cartridge 4/10, Amiodarone, Desethylamiodarone in serum/plasma
• 04250317519818: Precolum Cartridge 4/10, Levetiracetam (Keppra®) in serum/plasma
• 04250317519795: Precolumn Cartridge 4/10, Antiepileptic Drugs in serum/plasma
• 04250317519757: Precolum Cartridge 4/10, Metanephrines in urine
• 04250317502537: Precolum Cartridge 4/10, Benzodiazepines, Tricyclic Antidepressants in serum/plasma
• 04250317502506: Precolum Cartridge 4/10, Mycophenolic Acid in plasma/serum
• 04250317502452: Precolum Cartridge 4/10, Vitamin B2 in whole blood
• 04250317553461: PEEK-encased Prefilter