Identity
- Trade Name
- FLAER FDA UDI
- Generic Name
- Fluorescein-labelled aerolysin (FLAER) test IVD, reagent FDA UDI
- Device Name
- FLAER (Alexa 488 proaerolysin variant) liquid format-ASR FDA UDI
- Model / Reference
- FL2S FDA UDI
- Description
- FLAER (Alexa 488 proaerolysin variant) liquid format-ASR FDA UDI
Identifiers
- Catalog Number
- FL2S FDA UDI
- Primary DI / UDI-DI
- 00628451099376 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Fluorescein-labelled aerolysin (FLAER) test IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 50 Microgram FDA UDI
Category: Fluorescein-labelled aerolysin (FLAER) test IVD, reagent
Flaer by Cedarlane Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluorescein-labelled aerolysin (FLAER) test IVD, reagent.
- FLAER — Cedarlane Corporation · Class I
- FLAER — Cedarlane Corporation · Class I
- FLAER — Cedarlane Corporation · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cedarlane Corporation
Sources (1)
- FDA UDI d78864de-16a7-4699-84b5-283912bc4fe9 36 fields · synced May 30, 2026