Primary Device ID | 00630414597867 |
NIH Device Record Key | 6f9a2230-55be-4751-ab9f-84811dac6698 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Atellica™ IM aHCV |
Version Model Number | 10995456 |
Catalog Number | 10995456 |
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 | true |
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 |
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 |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend. |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00630414597867 [Primary] |
MZO | ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-09-30 |
Device Publish Date | 2018-10-16 |
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00630414626970 - ATELLICA IM NT-PBNPII (PBNPII) | 2024-02-13 PBNPII - ATELLICA IM - MCM Set |
00630414284927 - ADVIA Centaur PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 100T |
00630414284934 - ADVIA Centaur PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 500T |
00630414284941 - Atellica IM PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 100T |
00630414284958 - Atellica IM PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 500T |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ATELLICA 90362805 not registered Live/Pending |
Siemens Healthcare Diagnostics Inc. 2020-12-07 |
ATELLICA 88687795 not registered Live/Pending |
Siemens Healthcare Diagnostics Inc. 2019-11-11 |
ATELLICA 87651488 5652565 Live/Registered |
Siemens Healthcare Diagnostics Inc. 2017-10-19 |
ATELLICA 79185027 5097948 Live/Registered |
Siemens Healthcare Diagnostics Inc. 2016-01-12 |