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Prolex Latex Reagent Control Negative (Staph)

FDA UDI

Class I (US FDA UDI)

by Pro-Lab, Incorporated

Identity

Trade Name
Prolex Latex Reagent Control Negative (Staph) FDA UDI
Generic Name
Staphylococcus aureus culture isolate antigen IVD, control FDA UDI
Device Name
Negative Control Latex Reagent (PL.085B / PL.086B): One dropper bottle containing 2.5 ml (PL.080B) or 7.5 ml (PL.081B) of unsensitized latex particles suspended in a buffer containing 0.098% sodium azide as a preservative FDA UDI
Model / Reference
PL.085B FDA UDI
Description
Negative Control Latex Reagent (PL.085B / PL.086B): One dropper bottle containing 2.5 ml (PL.080B) or 7.5 ml (PL.081B) of unsensitized latex particles suspended in a buffer containing 0.098% sodium azide as a preservative FDA UDI

Identifiers

Catalog Number
PL.085B FDA UDI
Primary DI / UDI-DI
10628429000431 FDA UDI
FDA Product Code
GTN FDA UDI
GMDN Term
Staphylococcus aureus culture isolate antigen IVD, control 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

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: Staphylococcus aureus culture isolate antigen IVD, control

Prolex Latex Reagent Control Negative (Staph) by Pro-Lab, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Staphylococcus aureus culture isolate antigen IVD, control.

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 6125ce3f-b880-49c8-bf5f-e562451dec80 34 fields · synced May 30, 2026