Identity
- Trade Name
- Vysis FDA UDI
- Generic Name
- Human epidermal growth factor receptor 2 (HER2) protein IVD, control FDA UDI
- Device Name
- ProbeChek PathVysion HER-2/neu Cut-Off Control Slides FDA UDI
- Model / Reference
- 02J04-010 FDA UDI
- Description
- ProbeChek PathVysion HER-2/neu Cut-Off Control Slides FDA UDI
Identifiers
- Catalog Number
- 02J04-010 FDA UDI
- Primary DI / UDI-DI
- 00884999001824 FDA UDI
- 510(k) Number
- DEN040010 FDA UDI
- FDA Product Code
- NTH FDA UDI
- GMDN Term
- Human epidermal growth factor receptor 2 (HER2) protein IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.4700 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
Yes
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: Human epidermal growth factor receptor 2 (HER2) protein IVD, control
Vysis by Abbott Molecular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human epidermal growth factor receptor 2 (HER2) protein IVD, control.
- PATHWAY HER-2 4 in 1 Control Slides — Ventana Medical Systems · Class I
- ADVIA Centaur® H2n MCM — Siemens Healthcare Diagnostics · Class I
- HER2 neu Phospho control slides — BIO SB, INC. · Class I
- Atellica IM H2n QC — Siemens Healthcare Diagnostics · Class II
- HER-2 neu Control Slides — BIO SB, INC. · Class I
- HER2/ER/PR IHControls® — Boston Cell Standards, Inc. · Class II
- HER2/ER/PR IHControls® — Boston Cell Standards, Inc. · Class II
- HER2 neu control slides — BIO SB, INC. · Class I
Cleared under the same submission
DEN040010 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Abbott Molecular
Sources (1)
- FDA UDI 96453440-a1b0-4ebf-94b3-0ca72f407be1 37 fields · synced May 30, 2026