FDA UDI
In Commercial Distribution
🇺🇸 United States
Atellica™ IM HBsII Confirmatory
DI: 00630414599267
·
Model: 10995603
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Atellica™ IM HBsII Confirmatory
- Primary DI
- 00630414599267
- Version / Model
- 10995603
- Catalog Number
- 10995603
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-16
- Public Version
- 7
- Public Version Date
- 2026-02-12
- Public Version Status
- Update
- Public Device Record Key
- 7689f5c7-9144-4269-a552-2c4c0152b483
Device Description
HBsAg Confirmatory (HBsII Conf) - Atellica IM - RGT - 98T
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) | Microbiology | 866.3172 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60812 | Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative neutralization of Hepatitis B virus surface antigens in a clinical specimen, using Hepatitis B virus antibodies of known specificity and a chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414599267 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
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, Resuspend.