ADVIA® Chemistry TP Total Protein II Reagents B01-4601-01

GUDID 00630414465227

Total Protein - ADVIA Chem. - RGT - 4x850/4x700 tests

Siemens Healthcare Diagnostics Inc.

Total protein IVD, kit, enzyme spectrophotometry
Primary Device ID00630414465227
NIH Device Record Key8a08dc0e-4224-4546-aaa3-2141bb36e6ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameADVIA® Chemistry TP Total Protein II Reagents
Version Model Number10311878
Catalog NumberB01-4601-01
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
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 freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414465227 [Primary]

FDA Product Code

CEKBIURET (COLORIMETRIC), TOTAL PROTEIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

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Trademark Results [ADVIA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ADVIA
ADVIA
86019036 4590109 Live/Registered
First Community Federal Credit Union
2013-07-24
ADVIA
ADVIA
75167452 2162740 Live/Registered
SIEMENS HEALTHCARE DIAGNOSTICS INC.
1996-09-17
ADVIA
ADVIA
75167451 2177388 Live/Registered
SIEMENS HEALTHCARE DIAGNOSTICS INC.
1996-09-17
ADVIA
ADVIA
74647180 not registered Dead/Abandoned
ALLERGAN, INC.
1995-03-15
ADVIA
ADVIA
74246810 1838573 Dead/Cancelled
Alacritous Inc.
1992-02-18

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