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Prolex Staph Kit (300 Tests)

FDA UDI

Class I (US FDA UDI)

by Pro-Lab, Incorporated

Identity

Trade Name
Prolex Staph Kit (300 Tests) FDA UDI
Generic Name
Multiple Staphylococcus species nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
The Prolex™ Staph Latex Kit provides a rapid platform for the identification of Staphylococcal isolates particularly Staphylococcus aureus which possess bound coagulase (clumping factor) and / or protein A from other species of staphylococc FDA UDI
Model / Reference
PL.081B FDA UDI
Description
The Prolex™ Staph Latex Kit provides a rapid platform for the identification of Staphylococcal isolates particularly Staphylococcus aureus which possess bound coagulase (clumping factor) and / or protein A from other species of staphylococc FDA UDI

Identifiers

Catalog Number
PL.081B FDA UDI
Primary DI / UDI-DI
10628429000400 FDA UDI
FDA Product Code
GTN FDA UDI
GMDN Term
Multiple Staphylococcus species nucleic acid IVD, kit, nucleic acid technique (NAT) 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 species nucleic acid IVD, kit, nucleic acid technique (NAT)

Prolex Staph Kit (300 Tests) by Pro-Lab, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple Staphylococcus species nucleic acid IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pro-Lab, Incorporated

Sources (1)

  • FDA UDI d86df7fa-4d26-480f-90c0-8074f058d48b 34 fields · synced May 30, 2026