FDA UDI
In Commercial Distribution
🇺🇸 United States
Endotoxin Activity Assay (EAA)
DI: B173EAAST200
·
Model: EAAST-20
·
Spectral Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Endotoxin Activity Assay (EAA)
- Primary DI
- B173EAAST200
- Version / Model
- EAAST-20
- Catalog Number
- EAAST-20
- Company Name
- Spectral Medical Inc
- Labeler DUNS
- 248909939
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-18
- Public Version
- 2
- Public Version Date
- 2023-11-10
- Public Version Status
- Update
- Public Device Record Key
- 9742932b-fa84-48b1-89ae-a1bd3b99d51a
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NGS | Assay, Endotoxin Activity, Chemiluminescent | Microbiology | 866.3210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63586 | Lipopolyssacharide (LPS) IVD, kit, chemiluminescent immunoassay | A 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B173EAAST200 | HIBCC |
Customer Contacts
- Phone
- 18884264264
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius