Berichrom® Antithrombin III (A) OWWR15
GUDID 00842768013461
Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic Antithrombin III (ATIII) IVD, kit, chromogenic| Primary Device ID | 00842768013461 |
| NIH Device Record Key | a1250c4a-7918-4495-bd5c-9f14d99caff9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Berichrom® Antithrombin III (A) |
| Version Model Number | 10446672 |
| Catalog Number | OWWR15 |
| Company DUNS | 388240673 |
| Company Name | Siemens Healthcare Diagnostics Products GmbH |
| Device Count | 1 |
| 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(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842768013461 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K933125
FDA Product Code
| JPE | ANTITHROMBIN III, TWO STAGE CLOTTING TIME ASSAY |
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 | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Berichrom® Antithrombin III (A)]
| 00842768013478 | Determination of the functional activity of antithrombin III (AT III) in human plasma |
| 00842768013461 | Determination of the functional activity of antithrombin III (AT III) in human plasma |
Trademark Results [Berichrom]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BERICHROM 88117365 not registered Live/Pending |
Siemens Healthcare Diagnostics ProductsGmbH 2018-09-14 |
 BERICHROM 77075366 3497676 Dead/Cancelled |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTSGMBH 2007-01-03 |
 BERICHROM 73766409 1583270 Dead/Cancelled |
BEHRINGWERKE AKTIENGESELLSCHAFT 1988-11-30 |
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