Primary Device ID | 00842768006692 |
NIH Device Record Key | 425d205a-a4d3-480a-a3d8-edc929f5f357 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | N Latex IgG4 |
Version Model Number | 10445971 |
Catalog Number | OPAU03 |
Company DUNS | 388240673 |
Company Name | Siemens Healthcare Diagnostics Products 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 |
Phone | +1(800)664-3822 |
XX@XX.XX | |
Phone | +1(800)664-3822 |
XX@XX.XX | |
Phone | +1(800)664-3822 |
XX@XX.XX | |
Phone | +1(800)664-3822 |
XX@XX.XX | |
Phone | +1(800)664-3822 |
XX@XX.XX | |
Phone | +1(800)664-3822 |
XX@XX.XX | |
Phone | +1(800)664-3822 |
XX@XX.XX | |
Phone | +1(800)664-3822 |
XX@XX.XX | |
Phone | +1(800)664-3822 |
XX@XX.XX | |
Phone | +1(800)664-3822 |
XX@XX.XX | |
Phone | +1(800)664-3822 |
XX@XX.XX | |
Phone | +1(800)664-3822 |
XX@XX.XX | |
Phone | +1(800)664-3822 |
XX@XX.XX | |
Phone | +1(800)664-3822 |
XX@XX.XX | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
CONTACT@SIEMENS-HEALTHINEERS.COM | |
Phone | +1(800)664-3822 |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00842768006692 [Primary] |
DAS | IGG (FC FRAGMENT SPECIFIC), 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 |
00630414240336 - INNOVANCE Apixaban Controls | 2024-12-04 INNOVANCE Apixaban Controls |
00630414240343 - INNOVANCE Apixaban Standards | 2024-12-04 INNOVANCE Apixaban Standards |
00630414240404 - INNOVANCE Anti-Xa | 2024-12-04 In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma. |
00842768018800 - BC von Willebrand Reagent | 2024-09-20 Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination |
00842768019661 - LA 2 Confirmation Reagent | 2024-04-08 LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants |
00842768019654 - LA 1 Screening Reagent | 2024-04-08 LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants |
00842768019678 - LA Control Low | 2024-04-08 LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays |
00842768019685 - LA Control High | 2024-04-08 LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays |