FDA UDI
In Commercial Distribution
🇺🇸 United States
ADVIA Centaur® HBcT2 Quality Control Kit
DI: 00630414561233
·
Model: 10376699
·
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- ADVIA Centaur® HBcT2 Quality Control Kit
- Primary DI
- 00630414561233
- Version / Model
- 10376699
- Catalog Number
- 10376699
- Company Name
- SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Labeler DUNS
- 296822794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2023-06-20
- Public Version
- 1
- Public Version Date
- 2023-06-28
- Public Version Status
- New
- Public Device Record Key
- 327098ec-5b74-4c2b-8833-5665b6c51d45
Device Description
ADVIA Centaur® HBcT2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41984 | Hepatitis B virus core total antibody IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis B virus core antigen in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00630414210766 | GS1 | ||||
| Primary | 00630414561233 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P210019 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store upright, protect from light, do not freeze, and resuspend.