FDA.reportPublic FDA data

Smart Line TL Tube Luminometer

Primary DI
B173840070
Brand
Smart Line TL Tube Luminometer
Company
Spectral Medical Inc
Model
84007
Catalog number
84007
Device description
Smart Line TL Tube Luminometer is a stand-alone instrument with a built-in microprocessor software. Three softkeys and the 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 actionsperformed 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.
Published
2019-03-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B173840070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratory, semi-automatedAn electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or multiple technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature20 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify000-40°C up to 75% humidity (@30°C), non-condensing

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18884264264gguadagni@spectraldx.com

Regulatory Flags#

DUNS number
248909939
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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B173EAAST200Endotoxin Activity Assay (EAA)EAAST-20EAAST-202021-02-18
B173SA400000SAMI RRT CassetteSA-400-00SA-400-002018-03-05
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B173SA40000SAMI RRT CassetteSA-400-00SA-400-002018-03-05
B173SMC200Cassette CRRTSM-200-001SM-200-0012018-03-05
B173SMF200Cassette HemofiltrationSM-200-003SM-200-0032019-02-22
B173SM001SAMI CRRT UnitSM-100-003SM-100-0032018-02-22

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