← Back to catalogue

Teco Diagnostics

FDA UDI

Class II (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name
TECO DIAGNOSTICS FDA UDI
Generic Name
Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
Device Name
RPR, 1x100 Tests FDA UDI
Model / Reference
RPR-100 FDA UDI
Description
RPR, 1x100 Tests FDA UDI

Identifiers

Catalog Number
RPR-100 FDA UDI
Primary DI / UDI-DI
10673486000689 FDA UDI
510(k) Number
K864731 FDA UDI
FDA Product Code
GMQ FDA UDI
GMDN Term
Treponema pallidum reagin antibody IVD, kit, agglutination 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

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 reagin antibody IVD, kit, agglutination

Teco Diagnostics by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Treponema pallidum reagin antibody IVD, kit, agglutination.

Cleared under the same submission

K864731 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Teco Diagnostics

Sources (1)

  • FDA UDI d802dbb1-34d5-4d6a-83b0-b2df53a5bc49 37 fields · synced May 30, 2026