Urine Control 0474

GUDID 04250317551191

MassCheck® Amino Acids Analysis, Urine Control Level I

Chromsystems Instruments + Chemicals GmbH

Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control Multiple amino acid IVD, control

• Primary Device ID: 04250317551191
• NIH Device Record Key: 761d7e4b-8015-4560-a5e8-25c3589c16a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urine Control
• Version Model Number: 0474
• Catalog Number: 0474
• 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: false
• Expiration Date: true
• 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
• 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
• 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 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250317551160 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	04250317551191 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2022-07-18
• Device Publish Date: 2022-07-08

On-Brand Devices [Urine Control]

• 04250317501202: Urine Control Level II o-Cresol, p-Cresol, Phenol in urine
• 04250317501134: Urine Control Level I, o-Cresol, p-Cresol, Phenol in urine
• 04250317502179: Urine Control Level II, t,t-Muconic acid in urine
• 04250317502155: Urine Control Level I, t,t-Muconic acid in urine
• 04250317510952: Endocrine urine control, pathological range
• 04250317509383: Urine Control Level II Crosslinks in urine
• 04250317509093: Urine Control Level I, Crosslinks in urine
• 04250317507273: Endocrine urine control, normal range
• 04250317501301: Urine Control Level II, Porphyrins in urine
• 04250317501288: Urine Control Level I, Porphyrins in urine
• 04250317501257: Urine Control Level II, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Acids in urine
• 04250317501233: Urine Control Level I, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Acids in urine
• 04250317537027: MassCheck® Catecholamines, free Metanephrines, Serotonine, Urine Control Level II
• 04250317537010: MassCheck® Catecholamines, free Metanephrines, Serotonine, Urine Control Level I
• 04250317537003: MassCheck® VMA, HVA, 5-HIAA, Urine Control Level I
• 04250317536983: MassCheck® VMA, HVA, 5-HIAA, Urine Control Level II
• 04250317538956: MassCheck® total Metanephrines, Urine Control Level II
• 04250317538949: MassCheck® total Metanephrines, Urine Control Level I
• 04250317526014: MassCheck® Methylmalonic Acid Urine Control Level II
• 04250317526007: MassCheck® Methylmalonic Acid Urine Control Level I
• 04250317535795: MassCheck® Ethyl Glucuronide, Ethyl Sulfate, Urine Control Level III
• 04250317535788: MassCheck® Ethyl Glucuronide, Ethyl Sulfate, Urine Control Level II
• 04250317535771: MassCheck® Ethyl Glucuronide, Ethyl Sulfate, Urine Control Level I
• 04250317551184: MassCheck® Amino Acids Analysis, Plasma Control Level III
• 04250317551177: MassCheck® Amino Acids Analysis, Urine Control Level II
• 04250317551191: MassCheck® Amino Acids Analysis, Urine Control Level I