FDA UDI
In Commercial Distribution
🇺🇸 United States
Pneumococcus Anti CWPS high titer, 1 mL
DI: 05713106913048
·
Model: 91304
·
Ssi Diagnostica A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Pneumococcus Anti CWPS high titer, 1 mL
- Primary DI
- 05713106913048
- Version / Model
- 91304
- Catalog Number
- 91304
- 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
- 828a98e0-f41f-477c-9156-a61736843754
Device Description
Rabbit antiserum, High titer
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 |
|---|---|---|---|---|
| GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | Microbiology | 866.3740 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64703 | Streptococcus pneumoniae total antibody IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total antibodies to Streptococcus pneumoniae bacteria in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05713106913048 | GS1 |
Customer Contacts
- Phone
- +4548299100
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius