Azostix® Reagent Strips 2830

GUDID 00630414551142

AZOSTIX® is a firm, plastic strip to which is affixed an impregnated reagent area for estimating the amount of urea nitrogen in whole blood to provide information on renal function.

Siemens Healthcare Diagnostics Inc.

Urea IVD, kit, enzyme spectrophotometry
Primary Device ID00630414551142
NIH Device Record Key62a97647-281a-4f37-9fc0-22e1e91e5c41
Commercial Distribution StatusIn Commercial Distribution
Brand NameAzostix® Reagent Strips
Version Model Number10324060
Catalog Number2830
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414009544 [Unit of Use]
GS100630414551142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JMTDIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

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00630414313429 - Atellica CH Diazo Direct Bilirubin (D_DBil)2024-10-24 Atellica CH Diazo Direct Bilirubin (D_TBil)
00630414313436 - Atellica CH Diazo Total Bilirubin (D_TBil)2024-10-24 Atellica CH Diazo Total Bilirubin (D_TBil)
00630414317472 - Atellica Connect2024-09-19

Trademark Results [Azostix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AZOSTIX
AZOSTIX
72201640 0790907 Live/Registered
AMES COMPANY, INC.
1964-09-11

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