FDA UDI
In Commercial Distribution
🇺🇸 United States
Dimension® clinical chemistry system FPSA Flex® reagent cartridge
DI: 00842768013881
·
Model: 10444888
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Dimension® clinical chemistry system FPSA Flex® reagent cartridge
- Primary DI
- 00842768013881
- Version / Model
- 10444888
- Catalog Number
- RF452
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 005088112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 9
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- 0cc6a483-3571-4674-8f20-d40d0345ddfd
Device Description
Heterogeneous Immunoassay Module Free Prostate Specific Antigen Flex® reagent cartridge 120 Test
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 54668 | Free (unbound) prostate specific antigen (fPSA) 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 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, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768013881 | GS1 | ||||
| Unit of Use | 00630414601755 | GS1 |
Customer Contacts
- Phone
- +1(800)441-9250
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P020027 | 001 |
| P020027 | 003 |
| P020027 | 006 |
| P020027 | 008 |
| P020027 | 010 |
| P020027 | 012 |
| P020027 | 014 |
| P020027 | 017 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius