Atellica™ IM ThCG 10995689
GUDID 00630414600024
HCG Total (ThCG) Atellica IM - RGT - 450T
Siemens Healthcare Diagnostics Inc.
Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay| Primary Device ID | 00630414600024 |
| NIH Device Record Key | 6d4b1330-8fb6-498f-9cbd-a4f07a48567c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Atellica™ IM ThCG |
| Version Model Number | 10995689 |
| Catalog Number | 10995689 |
| Company DUNS | 064608573 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
Customer Support Contacts
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
Operating and Storage Conditions
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upright, Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414007816 [Unit of Use] |
| GS1 | 00630414600024 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172322
FDA Product Code
| JHI | Visual, pregnancy hCG, prescription use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-09-30 |
| Device Publish Date | 2018-06-05 |
On-Brand Devices [Atellica™ IM ThCG]
| 00630414600031 | HCG Total (ThCG) Atellica IM - RGT - 90T |
| 00630414600024 | HCG Total (ThCG) Atellica IM - RGT - 450T |
Trademark Results [Atellica]
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 |
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