FDA UDI
In Commercial Distribution
🇺🇸 United States
SAS Ultimate hCG Serum Contol Set
DI: 00780311000455
·
Model: 087715
·
SA SCIENTIFIC, LTD.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SAS Ultimate hCG Serum Contol Set
- Primary DI
- 00780311000455
- Version / Model
- 087715
- Company Name
- SA SCIENTIFIC, LTD.
- Labeler DUNS
- 122092117
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-01
- Public Version
- 2
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- f58c50c2-884e-46ca-ba7c-c8f922a71eda
Device Description
SAS™ Ultimate hCG Serum Controls are intended to be used to monitor the performance and accuracy of SAS™ Ultimate hCG pregnancy test kits. These controls are for professional use only.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38262 | Total human chorionic gonadotropin 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 total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00780311000455 | GS1 |