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Gram Stain Control Slides, Qty 10
EUDAMEDFDA UDIClass A (EU MDR)
Ref SS-250SAMModel Aerospray Stains
Identity
- Trade Name
- Gram Stain Control Slides, Qty 10 EUDAMEDGram Control Slides FDA UDI
- Generic Name
- Biological stain control IVD FDA UDI
- Device Name
- Colored slides to be used with Aerospray® Gram slide stainer/cytocentrifuges to aid in identifying cells. Qty. 10 FDA UDI
- Model / Reference
- Aerospray Stains EUDAMEDSS-250SAM EUDAMEDFDA UDI
- Description
- Colored slides to be used with Aerospray® Gram slide stainer/cytocentrifuges to aid in identifying cells. Qty. 10 FDA UDI
Identifiers
- Catalog Number
- SS-250SAM FDA UDI
- Primary DI / UDI-DI
- 03661540300387 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661540Aerospray-StainXL EUDAMED
- Direct Marketing DI
- 03661540300387 EUDAMED
- FDA Product Code
- LJG FDA UDI
- EMDN Code
- W02039085 VARIOUS MICROBIOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Biological stain control IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2660 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
Yes
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
Gram Stain Control Slides, Qty 10 by Elitechgroup Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 3661540Aerospray-StainXL | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- ELITechGroup Inc.
- EUDAMED SRN
- US-MF-000006942
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 0bf2ccec-1fd9-400d-b094-86cd7a19b3f0 61 fields · synced Jun 18, 2026
- FDA UDI 10d1d203-29af-46e7-a9dd-2fb188ae309b 35 fields · synced May 30, 2026