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Serodia TP-PA

FDA UDI

Class II (US FDA UDI)

by Fujirebio Diagnostics, Inc.

Identity

Trade Name
Serodia TP-PA FDA UDI
Generic Name
Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination FDA UDI
Device Name
100 test kit FDA UDI
Model / Reference
1626 FDA UDI
Description
100 test kit FDA UDI

Identifiers

Primary DI / UDI-DI
00850212007010 FDA UDI
510(k) Number
K971502 FDA UDI
FDA Product Code
GMT FDA UDI
GMDN Term
Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3830 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 immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination

Serodia TP-PA by Fujirebio Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination.

Cleared under the same submission

K971502 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fujirebio Diagnostics, Inc.

Sources (1)

  • FDA UDI 6b9bf974-4a88-401a-a0a7-ee35ac3a1809 37 fields · synced Jun 9, 2026