FDA UDI
In Commercial Distribution
🇺🇸 United States
Serodia TP-PA Kits
DI: 00869164000055
·
Model: 234952
·
FUJIREBIO DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Serodia TP-PA Kits
- Primary DI
- 00869164000055
- Version / Model
- 234952
- Company Name
- FUJIREBIO DIAGNOSTICS, INC.
- Labeler DUNS
- 079291908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-06
- Public Version
- 1
- Public Version Date
- 2023-12-14
- Public Version Status
- New
- Public Device Record Key
- 69bcf73a-82a6-45fc-9e84-6ebf36ed3128
Device Description
100 test kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| GMT | Antigens, Ha, Treponema Pallidum | Microbiology | 866.3830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61225 | Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Treponema pallidum in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00869164000055 | GS1 |
Customer Contacts
- Phone
- 800-531-7963
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K971502 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 100 tests per kit |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 56 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius