Urine Control 0474

GUDID 04250317551191

MassCheck® Amino Acids Analysis, Urine Control Level I

Chromsystems Instruments + Chemicals GmbH

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