Identity
- Trade Name
- QSlide™ FDA UDI
- Generic Name
- Biological stain control IVD FDA UDI
- Device Name
- A prepared slide containing dried and methanol fixed samples of S.aureus and E.coli for the quality control of Gram stain reagents on the Quickslide automated Gram stainers, and also for manual staining. 50 slides per case FDA UDI
- Model / Reference
- QS0700 FDA UDI
- Description
- A prepared slide containing dried and methanol fixed samples of S.aureus and E.coli for the quality control of Gram stain reagents on the Quickslide automated Gram stainers, and also for manual staining. 50 slides per case FDA UDI
Identifiers
- Catalog Number
- QS0700 FDA UDI
- Primary DI / UDI-DI
- 00819398026987 FDA UDI
- FDA Product Code
- LJG FDA UDI
- GMDN Term
- Biological stain control IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Biological stain control IVD
QSlide™ by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA UDI 8f8359bd-85d5-471d-8fb1-fcead09d4c41 35 fields · synced May 31, 2026