Identity
- Trade Name
- Microtiterplates EUDAMEDFDA UDI
- Generic Name
- Assay container IVD, single-use FDA UDI
- Device Name
- Microtiterplates EUDAMEDMicrotiterplates 48-well microtiter plates - bulk FDA UDI
- Model / Reference
- GSD-1600-W-CASE EUDAMEDFDA UDI
- Description
- Microtiterplates 48-well microtiter plates - bulk FDA UDI
Identifiers
- Catalog Number
- GSD-1600-W-CASE FDA UDI
- Primary DI / UDI-DI
- B350GSD1600WCASE0 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B350GSD1600WCASE0 EUDAMED
- 510(k) Number
- K150358 FDA UDI
- FDA Product Code
- GMQ FDA UDI
- EMDN Code
- W0105010399 SYPHILIS REAGENTS OTHER EUDAMED
- GMDN Term
- Assay container IVD, single-use FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3820 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Microtiterplates by Gold Standard Diagnostics, LLC — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-B350GSD1600WCASE0 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
- EUDAMED SRN
- US-MF-000027142
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 0b9a3894-fcfa-4748-b690-b2f00f17a071 61 fields · synced Jul 9, 2026
- FDA UDI d31931e0-8307-4e44-9243-1ed6e48ca1d5 35 fields · synced May 30, 2026