ADVIA® Chemistry A1c_3 Hemoglobin A1c Reagents 10485591
GUDID 00630414571270
HbA1c - ADVIA Chem. - RGT - 4x200 tests
Siemens Healthcare Diagnostics Inc.
Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry| Primary Device ID | 00630414571270 |
| NIH Device Record Key | 27b33a27-f694-45dd-9500-32c0541c21ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ADVIA® Chemistry A1c_3 Hemoglobin A1c Reagents |
| Version Model Number | 10485591 |
| Catalog Number | 10485591 |
| 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 | 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 |
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 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| 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 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414571270 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110934
FDA Product Code
| LCP | ASSAY, GLYCOSYLATED HEMOGLOBIN |
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 | 2019-10-14 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [ADVIA® Chemistry A1c_3 Hemoglobin A1c Reagents]
| 00630414571270 | HbA1c - ADVIA Chem. - RGT - 4x200 tests |
| 00630414569512 | HbA1c - ADVIA Chem. - RGT - 2x80 tests |
Trademark Results [ADVIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADVIA 86019036 4590109 Live/Registered |
First Community Federal Credit Union 2013-07-24 |
 ADVIA 75167452 2162740 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1996-09-17 |
 ADVIA 75167451 2177388 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1996-09-17 |
 ADVIA 74647180 not registered Dead/Abandoned |
ALLERGAN, INC. 1995-03-15 |
 ADVIA 74246810 1838573 Dead/Cancelled |
Alacritous Inc. 1992-02-18 |
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