FDA UDI
Not in Commercial Distribution
🇺🇸 United States
IMMULITE® Systems HBsAg Confirmatory Kit
DI: 00630414971544
·
Model: 10374036
·
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IMMULITE® Systems HBsAg Confirmatory Kit
- Primary DI
- 00630414971544
- Version / Model
- 10374036
- Catalog Number
- LKCH(D)
- Company Name
- SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Labeler DUNS
- 296822794
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 8
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- 50d902d8-7fc2-48f1-b36a-e4f4dd8142d8
- Distribution End Date
- 2018-10-31
Device Description
HBsAg Confirmatory Kit
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00630414971544 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010050 | 001 |
| P010050 | 006 |
| P010050 | 007 |
| P010050 | 008 |
| P010050 | 010 |
| P010050 | 011 |
| P010050 | 012 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from Light
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius