Primary Device ID | 00842768005985 |
NIH Device Record Key | 2715303d-ba8c-41a1-8f28-a21403046845 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Dimension Vista® a1-Acid Glycoprotein Flex® reagent cartridge |
Version Model Number | 10445883 |
Catalog Number | K7012 |
Company DUNS | 388240673 |
Company Name | Siemens Healthcare Diagnostics Products GmbH |
Device Count | 2 |
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 |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
XX@XX.XX | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)441-9250 |
CONTACT@SIEMENS-HEALTHINEERS.COM |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00842768005985 [Primary] |
GS1 | 00842768019869 [Unit of Use] |
LKL | ALPHA-1-ACID-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROL |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-10-02 |
Device Publish Date | 2020-09-24 |
00842768018589 - Control Plasma P | 2024-02-27 Assayed control used to monitor the performance of coagulation assays in the pathological range |
00842768018909 - Control Plasma N | 2024-02-27 Assayed control used to monitor the performance of coagulation assays in the normal range |
00842768018886 - Coagulation Factor V Deficient Plasma | 2024-02-27 For the determination of the activity of coagulation factor V in human plasma by coagulometric methods |
00842768006661 - vWF Ag | 2023-06-26 For the quantitative determination of von Willebrand factor (vWF) antigen concentration in human sodium citrated plasma |
00842768028014 - INNOVANCE VWF Ac | 2022-10-18 In-vitro diagnostic automated assay for the quantitative determination of the von Willebrandfactor-GPIb-binding activity in huma |
00630414287430 - N LP(a) Standard SY | 2020-10-20 Calibration of Lp(a) assay on BN Systems |
00630414287416 - N/T Rheumatology Control SL/1 | 2020-10-02 Assayed control for RF, ASL and CRP assays on BN Systems |
00630414287423 - N/T Rheumatology Control SL/2 | 2020-10-02 Assayed control for RF, ASL and CRP assays on BN Systems |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIMENSION VISTA 87350896 5290516 Live/Registered |
Siemens Healthcare Diagnostics Inc. 2017-02-27 |
DIMENSION VISTA 78480379 3199475 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 2004-09-08 |
DIMENSION VISTA 76515533 not registered Dead/Abandoned |
Dade Behring Inc. 2003-05-19 |
DIMENSION VISTA 76511472 3117538 Dead/Cancelled |
Dade Behring Inc. 2003-05-06 |