FDA UDI
In Commercial Distribution
🇺🇸 United States
INNOVANCE Free PS Ag
DI: 00842768039522
·
Model: 10873458
·
Siemens Healthcare Diagnostics Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INNOVANCE Free PS Ag
- Primary DI
- 00842768039522
- Version / Model
- 10873458
- Catalog Number
- OPGL07
- Company Name
- Siemens Healthcare Diagnostics Products GmbH
- Labeler DUNS
- 388240673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-15
- Public Version
- 4
- Public Version Date
- 2024-02-20
- Public Version Status
- Update
- Public Device Record Key
- 4788a1ee-1074-4921-a8df-855513354ca3
Device Description
For the quantitative determination of free protein S antigen in human plasma collected from venous blood samplesin 3.2 % sodium citrate tubes on the BCS XP System, the SYSMEX CS-2500 analyzer and the SYSMEX CS-5100 analyzer.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | Hematology | 864.7290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60497 | Protein S IVD, kit, nephelometry/turbidimetry | A collection of reagents and other associated materials intended to be used for the quantitative measurement of protein S in a clinical specimen, using a nephelometry/turbidimetry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768039522 | GS1 |
Customer Contacts
- Phone
- +1(800)664-3822
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181525 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius