FDA UDI
In Commercial Distribution
🇺🇸 United States
Elecsys free PSA
DI: 07613336154397
·
Model: 03289788160
·
Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Elecsys free PSA
- Primary DI
- 07613336154397
- Version / Model
- 03289788160
- Catalog Number
- 03289788160
- 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
- 7
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- b9c88d71-ae43-481d-8c42-719216d9de52
Device Description
fPSA reagent
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 |
|---|---|---|---|---|
| MTG | Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38182 | Free (unbound) prostate specific antigen (fPSA) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of free (unbound) prostate specific antigen (fPSA) in any of the isoforms [i.e., benign PSA (BPSA), inactive/intact PSA, and/or the PSA precursor, proPSA] in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 04015630919321 | GS1 | ||||
| Primary | 07613336154397 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P000027 | 023 |
| P000027 | 034 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius