FDA UDI
In Commercial Distribution
🇺🇸 United States
ImmuLex Pneumococcus Factor 25b, 1.5 mL
DI: 05713106989272
·
Model: 98927
·
Ssi Diagnostica A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- ImmuLex Pneumococcus Factor 25b, 1.5 mL
- Primary DI
- 05713106989272
- Version / Model
- 98927
- Catalog Number
- 98927
- Company Name
- Ssi Diagnostica A/S
- Labeler DUNS
- 305684449
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-01
- Public Version
- 1
- Public Version Date
- 2021-08-09
- Public Version Status
- New
- Public Device Record Key
- 934bd120-1eb8-4787-b8d8-32fab4523ab6
Device Description
Rabbit antiserum, Ready to use
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
- Yes
- 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 |
|---|---|---|---|---|
| GWC | ANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE | Microbiology | 866.3740 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51772 | Streptococcus pneumoniae culture isolate antigen IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative detection of antigens from Streptococcus pneumoniae bacteria isolated by culture from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05713106989272 | GS1 |
Customer Contacts
- Phone
- +4548299100
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius