Identity
- Trade Name
- Bioeasy Immunofluorescence Analyzer FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Model / Reference
- EASY-11 FDA UDI
Identifiers
- Catalog Number
- YRLE01106 FDA UDI
- Primary DI / UDI-DI
- 06974521006626 FDA UDI
- 510(k) Number
- K220046 FDA UDI
- FDA Product Code
- KHO FDA UDI
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Fluorescent immunoassay analyser IVD, laboratory
Bioeasy Immunofluorescence Analyzer by Shenzhen Superbio Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Fluorescent immunoassay analyser IVD, laboratory.
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- VIDAS® — BIOMERIEUX , INC. · Class II
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- AutoDELFIA Plate processor — Wallac, Inc. · Class I
Cleared under the same submission
K220046 also covers:
- Carolina Liquid Chemistries Corp. Fentanyl Detection Kit — Carolina Liquid Chemistries Corp.
- S-Trust Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay) — Shenzhen Superbio Technology Co., Ltd.
- U-Catch Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay) — Shenzhen Superbio Technology Co., Ltd.
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
- Shenzhen Superbio Technology Co., Ltd.
Sources (1)
- FDA UDI 3ef823fa-f40e-403c-a455-bda0c959b3db 34 fields · synced Jun 6, 2026