FDA UDI
In Commercial Distribution
🇺🇸 United States
Bordetella Pertussis IgG
DI: 07290016332636
·
Model: A2231-01M
·
SAVYON DIAGNOSTICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bordetella Pertussis IgG
- Primary DI
- 07290016332636
- Version / Model
- A2231-01M
- Catalog Number
- A2231-01M
- Company Name
- SAVYON DIAGNOSTICS LTD
- Labeler DUNS
- 533708202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-16
- Public Version
- 2
- Public Version Date
- 2023-08-11
- Public Version Status
- Update
- Public Device Record Key
- deaab7d8-2be0-4f6b-a034-246a764dd9d7
Device Description
Bordetella Pertussis IgG kit is an Enzyme Linked Immunosorbent assay (ELISA) for the qualitative detection of specific IgG antibodies to Bordetella pertussis.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| GOZ | Antisera, Fluorescent, B. Pertussis | Microbiology | 866.3065 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50517 | Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA) antibodies to Bordetella pertussis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Bordetella pertussis, the bacteria associated with whooping cough. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016332636 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius