FDA.reportPublic FDA data

Endotoxin Activity Assay (EAA)

Primary DI
B173EAAST200
Brand
Endotoxin Activity Assay (EAA)
Company
Spectral Medical Inc
Model
EAAST-20
Catalog number
EAAST-20
Device description
The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens.
Published
2021-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NGSAssay, Endotoxin Activity, Chemiluminescent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGSAssay, Endotoxin Activity, ChemiluminescentMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B173EAAST200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Lipopolyssacharide (LPS) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of lipopolysaccharides, also known as endotoxin, in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to determine endotoxin activity, to aid in the diagnosis and treatment of disorders associated with exposure to bacterial endotoxin (e.g., sepsis and post-traumatic/postsurgical infection).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18884264264shung@spectraldx.com
18884264264ppujara@spectraldx.com

Regulatory Flags#

DUNS number
248909939
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B173EAASTNA0Endotoxin Activity Assay (EAA)EAAST-NAEAAST-NA2018-01-09
B173840070Smart Line TL Tube Luminometer84007840072019-03-14
B17384018010Sirius 2 Tube Luminometer84018-0184018012025-03-21
B173SA400000SAMI RRT CassetteSA-400-00SA-400-002018-03-05
B173SM1000030SAMI RRTSM-100-003SM-100-0032018-02-22
B173SM2000030SAMI Hemofiltration CassetteSM-200-003SM-200-0032019-02-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B173EAASTNA0Endotoxin Activity Assay (EAA)Spectral Medical IncNGS2018-01-09