Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry 5085

GUDID 00630414479095

Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry for use with Clintek Atlas® Urine Chemistry Analyzer

Siemens Healthcare Diagnostics Inc.

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid

Primary Device ID	00630414479095
NIH Device Record Key	5155cbf1-ea88-4db4-a763-27abb47b6ee0
Commercial Distribution Status	In Commercial Distribution
Brand Name	Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry
Version Model Number	10315660
Catalog Number	5085
Company DUNS	064608573
Company Name	Siemens Healthcare Diagnostics Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Do not refrigerate.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414479095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K021428

FDA Product Code

CEN	DYE-INDICATOR, PH (URINARY, NON-QUANT.)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-24

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