FDA UDI
In Commercial Distribution
🇺🇸 United States
Salmonella Phase H:z39 serum, 3 mL
DI: 05713106403136
·
Model: 40313
·
Ssi Diagnostica A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Salmonella Phase H:z39 serum, 3 mL
- Primary DI
- 05713106403136
- Version / Model
- 40313
- Catalog Number
- 40313
- Company Name
- Ssi Diagnostica A/S
- Labeler DUNS
- 305684449
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 4
- Public Version Date
- 2021-07-26
- Public Version Status
- Update
- Public Device Record Key
- d2666327-fe66-4bb0-9cb1-b49ea3dabe5c
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 |
|---|---|---|---|---|
| GRM | Antisera, All Groups, Salmonella Spp. | Microbiology | 866.3550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51514 | Multiple Salmonella species 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 one or multiple species of Salmonella 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 | 05713106403136 | GS1 |
Customer Contacts
- Phone
- +4548299100
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius