← Back to catalogue
AFB/TB Stain Control Slides
EUDAMEDFDA UDIClass A (EU MDR)
Ref SS-249Model Aerospray Stains
Identity
- Trade Name
- AFB/TB Stain Control Slides EUDAMEDAcid Fast Control Slide (pack of 50 slides) FDA UDI
- Generic Name
- Biological stain control IVD FDA UDI
- Device Name
- Colored slides to be used with Aerospray® TB slide stainer/cytocentrifuges to aid in identifying cells. FDA UDI
- Model / Reference
- Aerospray Stains EUDAMEDSS-249 EUDAMEDFDA UDI
- Description
- Colored slides to be used with Aerospray® TB slide stainer/cytocentrifuges to aid in identifying cells. FDA UDI
Identifiers
- Catalog Number
- SS-249 FDA UDI
- Primary DI / UDI-DI
- 03661540303982 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661540Aerospray-StainXL EUDAMED
- Direct Marketing DI
- 03661540303982 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
AFB/TB Stain Control Slides 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ELITechGroup Inc.
- EUDAMED SRN
- US-MF-000006942
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 54c2359d-df4d-40d4-85e3-ada0077a2518 61 fields · synced Jun 17, 2026
- FDA UDI 28812537-37ad-45bf-9088-83ccbc70ec0a 35 fields · synced May 30, 2026