Identity
- Trade Name
- Dako Omnis Vial with Mixing Ball, 2 mL EUDAMEDDako FDA UDI
- Generic Name
- Assay stirring set IVD FDA UDI
- Device Name
- Dako Omnis Vial with Mixing Ball, 2 mL EUDAMEDDako Omnis Vial with Mixing Ball, 2 mL FDA UDI
- Model / Reference
- GC206 EUDAMEDFDA UDIGC20630-7 EUDAMED
- Description
- Dako Omnis Vial with Mixing Ball, 2 mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571107713 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057P3007P3010A056701PW EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202059085 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES EUDAMED
- GMDN Term
- Assay stirring set IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3800 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2 Milliliter FDA UDI
Category: Assay stirring set IVD
Dako by Agilent Technologies Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Assay stirring set IVD.
- TintoMixing Station Kit — BIO SB, INC. · Class I
- Bioseal Inc. — BIOSEAL · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Inc.
Sources (2)
- FDA UDI f032adc9-2faf-48a7-85a1-52fe4eadeab7 36 fields · synced Jul 19, 2026
- EUDAMED 3e51e653-4ef9-4fc9-9395-eba44ab54c44 61 fields · synced Jul 19, 2026