FDA UDI
In Commercial Distribution
🇺🇸 United States
Elecsys tPSA
DI: 07613336154366
·
Model: 04641655160
·
Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Elecsys tPSA
- Primary DI
- 07613336154366
- Version / Model
- 04641655160
- Catalog Number
- 04641655160
- Company Name
- Roche Diagnostics GmbH
- Labeler DUNS
- 315028860
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-29
- Public Version
- 6
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 1128354f-f86f-43ce-ae36-18e78719f5cd
Device Description
tPSA reagent, 100 Test-Kit
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54665 | Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay | 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 a chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 04015630921515 | GS1 | ||||
| Primary | 07613336154366 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P990056 | 024 |
| P990056 | 036 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius