Smart Line TL Tube Luminometer
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Basic Information
- Brand Name
- Smart Line TL Tube Luminometer
- Primary DI
- B173840070
- Version / Model
- 84007
- Catalog Number
- 84007
- Company Name
- Spectral Medical Inc
- Labeler DUNS
- 248909939
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-14
- Public Version
- 3
- Public Version Date
- 2025-04-15
- Public Version Status
- Update
- Public Device Record Key
- ae8089b1-1d96-4820-9821-eaf603f88d71
Device Description
Smart Line TL Tube Luminometer is a stand-alone instrument with a built-in microprocessor software. Three softkeys and the <esc> key are all you need to operate the luminometer. Menus and parameters for functions that are not automated, are selected via these softkeys. The display shows the menu items, the actions performed and the user prompts. The luminometer includes an internal reading device for chip cards. Measurement protocols are saved on this chip card. During this procedure the user is prompted step by step to place the required tubes into the instrument for measurement. This ensures a high level of automation and standardization of the measurement process.
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56676 | Multiple clinical chemistry analyser IVD, laboratory | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B173840070 | HIBCC |
Customer Contacts
- Phone
- 18884264264
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Not Applicable |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 60 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- 0-40°C up to 75% humidity (@30°C), non-condensing