FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Salmonella H Phase Pool HMG serum, 1 mL
DI: 05713106735367
·
Model: 73536
·
Ssi Diagnostica A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Salmonella H Phase Pool HMG serum, 1 mL
- Primary DI
- 05713106735367
- Version / Model
- 73536
- Catalog Number
- 73536
- Company Name
- Ssi Diagnostica A/S
- Labeler DUNS
- 305684449
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 5
- Public Version Date
- 2023-10-05
- Public Version Status
- Update
- Public Device Record Key
- c6459a88-c3e1-4fd0-87c6-694413155f12
- Distribution End Date
- 2023-07-31
Device Description
Rabbit anitserum, 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 |
|---|---|---|---|---|
| 51519 | Multiple Salmonella species antigen IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple species of Salmonella bacteria in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05713106735367 | GS1 |
Customer Contacts
- Phone
- +4548299100
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius