ADVIA Centaur® HBcT2 Quality Control Kit 10376699
GUDID 00630414210766
ADVIA Centaur® HBcT2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Hepatitis B virus core total antibody IVD, control| Primary Device ID | 00630414210766 |
| NIH Device Record Key | 327098ec-5b74-4c2b-8833-5665b6c51d45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ADVIA Centaur® HBcT2 Quality Control Kit |
| Version Model Number | 10376699 |
| Catalog Number | 10376699 |
| Company DUNS | 296822794 |
| Company Name | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| Device Count | 2 |
| 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
Operating and Storage Conditions
| 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and 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, and resuspend. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414210766 [Unit of Use] |
| GS1 | 00630414561233 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P210019
FDA Product Code
| LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
| SEI | Qualitative and Quantitative Hepatitis B Virus Antibody assays |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-28 |
| Device Publish Date | 2023-06-20 |
Devices Manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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| 00630414245355 - ADVIA Centaur Anti-Thyroglobulin II (aTgII) | 2026-02-12 ADVIA Centaur Anti-Thyroglobulin II (aTgII) - 100T |
| 00630414245362 - ADVIA Centaur Anti-Thyroglobulin II (aTgII) | 2026-02-12 ADVIA Centaur Anti-Thyroglobulin II (aTgII) - 500T |
| 00630414245379 - ADVIA Centaur aTgII Quality Control (aTgII QC) | 2026-02-12 ADVIA Centaur aTgII Quality Control Material |
| 00630414245386 - ADVIA Centaur aTgII Master Curve Material (aTgII MCM) | 2026-02-12 ADVIA Centaur aTgII Master Curve Material |
Trademark Results [ADVIA Centaur]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADVIA CENTAUR 75658644 2427460 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1999-03-11 |
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