Identity
- Trade Name
- ASI Staphslide Test FDA UDI
- Generic Name
- Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI
- Device Name
- Detection of coagulase associated with Staph. aureus FDA UDI
- Model / Reference
- NC-280-2C FDA UDI
- Description
- Detection of coagulase associated with Staph. aureus FDA UDI
Identifiers
- Catalog Number
- NC-280-2C FDA UDI
- Primary DI / UDI-DI
- 00816057020102 FDA UDI
- 510(k) Number
- K855220 FDA UDI
- FDA Product Code
- JWX FDA UDI
- GMDN Term
- Staphylococcus aureus culture isolate antigen IVD, kit, agglutination 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
ASI Staphslide Test by Arlington Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Staphylococcus aureus culture isolate antigen IVD, kit, agglutination.
- StaphTEX™ — HARDY DIAGNOSTICS · Class I
- Remel — REMEL, INC. · Class I
- StaphTEX™ — HARDY DIAGNOSTICS · Class I
- Pastorex — Bio-Rad · Class I
- BD BBL™ Staphyloslide™ Latex Test Kit — BECTON DICKINSON AND COMPANY · Class I
- Pastorex — Bio-Rad · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Remel — REMEL, INC. · Class I
Cleared under the same submission
K855220 also covers:
- ASI Staphslide Control Set — Arlington Scientific, Inc.
- ASI Staphslide Test — Arlington Scientific, Inc.
- ASI Staphslide Test — Arlington Scientific, Inc.
- ASI Staphslide Test — Arlington Scientific, Inc.
- ASI Staphslide Test — Arlington Scientific, Inc.
- ASI Staphslide Test — Arlington Scientific, Inc.
- CARDINAL HEALTH — Cardinal Health 200, LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Arlington Scientific, Inc.
Sources (1)
- FDA UDI 160d2693-b407-4f11-b8b5-b66e791814f5 38 fields · synced Jul 18, 2026