FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Glycated Serum Protein Linearity Set
DI: 00657498001134
·
Model: 2380-201
·
STANBIO LABORATORY, L.P.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Glycated Serum Protein Linearity Set
- Primary DI
- 00657498001134
- Version / Model
- 2380-201
- Catalog Number
- 2380-201
- Company Name
- STANBIO LABORATORY, L.P.
- Labeler DUNS
- 045361136
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2019-04-08
- Public Version Status
- Update
- Public Device Record Key
- 9c8138e4-7a40-443d-b1ae-f7b39e0c3d25
- Distribution End Date
- 2019-04-05
Device Description
Stanbio Glycated Serum Protein (GSP) Linearity Set is intended to be used for quality control procedures in verifying the linearity throughout the reportable range of Stanbio’s Glycated Serum Protein (GSP) LiquiColor®. For in-vitro diagnostic use only.
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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53276 | Fructosamine IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the glycated serum protein fructosamine in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00657498001134 | GS1 |
Customer Contacts
- Phone
- 18005315535
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius