Identity
- Trade Name
- Prolex Staph Xtra Latex Kit (300 tests) FDA UDI
- Generic Name
- Multiple Staphylococcus bacterial species culture isolate identification IVD, kit FDA UDI
- Device Name
- Staph Xtra Latex Reagent (2 x 2.5 ml) Negative Control Latex Reagent (5.0 ml) Agglutination Cards (20) Mixing Sticks (200) FDA UDI
- Model / Reference
- PL.1081 FDA UDI
- Description
- Staph Xtra Latex Reagent (2 x 2.5 ml) Negative Control Latex Reagent (5.0 ml) Agglutination Cards (20) Mixing Sticks (200) FDA UDI
Identifiers
- Catalog Number
- PL.1081 FDA UDI
- Primary DI / UDI-DI
- 10628429000479 FDA UDI
- FDA Product Code
- GTN FDA UDI
- GMDN Term
- Multiple Staphylococcus bacterial species culture isolate identification IVD, kit 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: Multiple Staphylococcus bacterial species culture isolate identification IVD, kit
Prolex Staph Xtra Latex Kit (300 tests) by Pro-Lab, Incorporated — 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
- Pro-Lab, Incorporated
Sources (1)
- FDA UDI 19536db7-05de-4cd6-b775-07802ca2141e 34 fields · synced Jun 8, 2026