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Treponema pallidum (Spirochete)

FDA UDI

Class I (US FDA UDI)

by Biocare Medical, Llc

Identity

Trade Name
Treponema pallidum (Spirochete) FDA UDI
Generic Name
Treponema pallidum antigen IVD, antibody FDA UDI
Model / Reference
ACA135B FDA UDI

Identifiers

Primary DI / UDI-DI
00847627001368 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Treponema pallidum antigen IVD, antibody FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 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

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: Treponema pallidum antigen IVD, antibody

Treponema pallidum (Spirochete) by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Treponema pallidum antigen IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biocare Medical, Llc

Sources (1)

  • FDA UDI 348073fc-a4cf-4d73-be1c-9b7e5a65c798 33 fields · synced May 30, 2026