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Endotoxin Activity Assay (EAA)

FDA UDI

Class II (US FDA UDI)

by Spectral Medical Inc

Identity

Trade Name
Endotoxin Activity Assay (EAA) FDA UDI
Generic Name
Lipopolyssacharide (LPS) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
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. FDA UDI
Model / Reference
EAAST-20 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
EAAST-20 FDA UDI
Primary DI / UDI-DI
B173EAAST200 FDA UDI
FDA Product Code
NGS FDA UDI
GMDN Term
Lipopolyssacharide (LPS) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3210 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Lipopolyssacharide (LPS) IVD, kit, chemiluminescent immunoassay

Endotoxin Activity Assay (EAA) by Spectral Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lipopolyssacharide (LPS) IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spectral Medical Inc

Sources (1)

  • FDA UDI 9742932b-fa84-48b1-89ae-a1bd3b99d51a 36 fields · synced May 30, 2026