FDA UDI
In Commercial Distribution
🇺🇸 United States
Stratus® CS Acute Care™ ßhCG TestPak
DI: 00842768004407
·
Model: 10445060
·
Siemens Healthcare Diagnostics Inc.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Stratus® CS Acute Care™ ßhCG TestPak
- Primary DI
- 00842768004407
- Version / Model
- 10445060
- Catalog Number
- CBHCG
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 005088112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2021-11-19
- Public Version Status
- Update
- Public Device Record Key
- 31a642a6-bd74-4dce-9ed1-5e76c3829ca5
Device Description
The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin method (ßhCG) is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free ß subunit, of the human chorionic gonadotropin hormone in heparinized plasma.
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 |
|---|---|---|---|---|
| DHA | SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN | Clinical Chemistry | 862.1155 | 2 |
| NBC | TEST,NATRIURETIC PEPTIDE | Clinical Chemistry | 862.1117 | 2 |
| JIT | CALIBRATOR, SECONDARY | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58789 | Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, in a clinical specimen using a fluorescent immunoassay method. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768004407 | GS1 | ||||
| Unit of Use | 00630414009759 | GS1 |
Customer Contacts
- Phone
- +1(800)405-6473
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060548 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius