Identity
- Trade Name
- IntraStain EUDAMEDFDA UDI
- Generic Name
- Specimen stabilization reagent IVD FDA UDI
- Device Name
- IntraStain EUDAMEDFDA UDI
- Model / Reference
- K2311 EUDAMEDFDA UDIK231111-2 EUDAMED
- Description
- IntraStain FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572004387 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057P3006P3008A054701S8 EUDAMED
- FDA Product Code
- GGK FDA UDI
- EMDN Code
- W0103080599 AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER EUDAMED
- GMDN Term
- Specimen stabilization reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.8540 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
Yes
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
Category: Specimen stabilization reagent IVD
IntraStain by Agilent Technologies Singapore Pte Ltd — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Specimen stabilization reagent IVD.
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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 Singapore Pte Ltd
Sources (2)
- FDA UDI 0e9b9418-0307-4893-a42d-70f4fe34cd0c 36 fields · synced Jul 18, 2026
- EUDAMED 718fd23e-4ea4-4911-a9d3-20178ba166e2 61 fields · synced Jul 18, 2026