FDA UDI
In Commercial Distribution
🇺🇸 United States
STAT-Site M B-HB Analyzer Pack
DI: 00657498000083
·
Model: 400400
·
STANBIO LABORATORY, L.P.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STAT-Site M B-HB Analyzer Pack
- Primary DI
- 00657498000083
- Version / Model
- 400400
- Catalog Number
- 400400
- Company Name
- STANBIO LABORATORY, L.P.
- Labeler DUNS
- 045361136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-04-16
- Public Version Status
- Update
- Public Device Record Key
- 24fbd61c-cc95-43f2-b880-914d73093aff
Device Description
The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the quantitative determination of ß-hydroxybutyrate in serum or plasma.
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Clinical Chemistry | 862.1435 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56681 | Single-channel clinical chemistry analyser IVD, point-of-care | A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative determination of one or multiple clinical chemistry analytes in a clinical specimen. Analytes measured include multiple clinical chemistry analytes such as glucose, ketone, specific proteins, clinical chemistry substrates, enzymes and/or a lipid profile, using a single technology such as electrometry, spectrophotometry, fluorimetry, radiometry or chemiluminescence. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00657498000083 | GS1 |
Customer Contacts
- Phone
- 18005315535
- [email protected]