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RPR (Syphilis) Tri-Level Controls

FDA UDI

Class II (US FDA UDI)

by Stanbio Laboratory, L.p.

Identity

Trade Name
RPR (Syphilis) Tri-Level Controls FDA UDI
Generic Name
Treponema pallidum antigen IVD, control FDA UDI
Device Name
For Use As Quality Control Material In The VDRL Slide Flocculation Test and For The Rapid Plasma Reagin (RPR) 18mm Circle Syphilis Card Test. FDA UDI
Model / Reference
1175-305 FDA UDI
Description
For Use As Quality Control Material In The VDRL Slide Flocculation Test and For The Rapid Plasma Reagin (RPR) 18mm Circle Syphilis Card Test. FDA UDI

Identifiers

Catalog Number
1175-305 FDA UDI
Primary DI / UDI-DI
00657498001196 FDA UDI
FDA Product Code
GMQ FDA UDI
GMDN Term
Treponema pallidum antigen IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3820 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

Yes

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

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: Treponema pallidum antigen IVD, control

RPR (Syphilis) Tri-Level Controls by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Treponema pallidum antigen IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stanbio Laboratory, L.p.

Sources (1)

  • FDA UDI 9b550562-0f27-4c52-a471-4f6a04fd202c 36 fields · synced May 30, 2026