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Bio-Stat

FDA UDI

Class II (US FDA UDI)

by Clark Laboratories, Inc.

Identity

Trade Name
Bio-Stat FDA UDI
Generic Name
Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Syphilis EIA (Non-US sales only) FDA UDI
Model / Reference
YY60126 FDA UDI
Description
Syphilis EIA (Non-US sales only) FDA UDI

Identifiers

Primary DI / UDI-DI
05391516746588 FDA UDI
FDA Product Code
LIP FDA UDI
GMDN Term
Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA) 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

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: Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA)

Bio-Stat by Clark Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clark Laboratories, Inc.

Sources (1)

  • FDA UDI 481a8b5e-76f9-454f-bb0f-18fc3c911d41 36 fields · synced May 30, 2026