FDA UDI
Not in Commercial Distribution
🇺🇸 United States
VIDAS®
DI: 03573026156985
·
Model: TPSA
·
BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VIDAS®
- Primary DI
- 03573026156985
- Version / Model
- TPSA
- Catalog Number
- 30428-01
- Company Name
- BIOMERIEUX SA
- Labeler DUNS
- 276816717
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-23
- Public Version
- 4
- Public Version Date
- 2020-02-06
- Public Version Status
- Update
- Public Device Record Key
- 4bc87b37-a9db-4eed-a982-b7a49be1f361
- Distribution End Date
- 2017-03-23
Device Description
VIDAS® TPSA is a In Vitro Diagnostic kit for the quantitative detection of total prostate specific antigen (PSA) in human serum, using an enzyme immunoassay (EIA) method.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54664 | Total prostate specific antigen (tPSA) 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 total prostate specific antigen (tPSA) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03573026156985 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P040008 | 000 |
| P040008 | 001 |
| P040008 | 002 |
| P040008 | 003 |
| P040008 | 004 |
| P040008 | 005 |
| P040008 | 006 |
| P040008 | 007 |
| P040008 | 008 |
| P040008 | 011 |
| P040008 | 012 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius