Identity
- Trade Name
- StaphTEX™ FDA UDI
- Generic Name
- Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI
- Device Name
- StaphTEX™ Blue test kit, 200 tests. A rapid, latex agglutination slide-card test for the detection of coagulase clumping factor and/or protein A characteristics associated with Staphylococcus aureus. FDA UDI
- Model / Reference
- ST200 FDA UDI
- Description
- StaphTEX™ Blue test kit, 200 tests. A rapid, latex agglutination slide-card test for the detection of coagulase clumping factor and/or protein A characteristics associated with Staphylococcus aureus. FDA UDI
Identifiers
- Catalog Number
- ST200 FDA UDI
- Primary DI / UDI-DI
- 00819398028042 FDA UDI
- FDA Product Code
- GTN FDA UDI
- GMDN Term
- Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3700 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
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
Category: Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
StaphTEX™ 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 a00f614c-8666-49e0-a73a-4bc75a2991fb 35 fields · synced May 30, 2026