FDA UDI
In Commercial Distribution
🇺🇸 United States
TPHA Screen
DI: 10888234001485
·
Model: 0066826
·
IMMUCOR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TPHA Screen
- Primary DI
- 10888234001485
- Version / Model
- 0066826
- Catalog Number
- 0066826
- Company Name
- IMMUCOR, INC.
- Labeler DUNS
- 061446282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-15
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 64a52ad9-874c-42fe-9dd3-00c8f863ebcf
Device Description
TPHA Screen is used in the qualitative screening of blood donors for the detection of IgG and IgM antibodies to Treponema pallidum in human serum and EDTA plasma by passive hemagglutination using an automated Blood Bank system. The product configuration is ten (10) vials.
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
- 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 |
|---|---|---|---|---|
| MYR | Test,Donor,Syphilis,Antigens,Treponemal | Microbiology | 866.3830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51800 | Treponema pallidum total antibody IVD, kit, agglutination | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total 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 | 10888234001485 | GS1 |
Customer Contacts
- Phone
- 1-855-466-8267
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 10 Degrees Celsius