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Access Syphilis Reagent

FDA UDI

Class II (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name
Access Syphilis Reagent FDA UDI
Generic Name
Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
The Access Syphilis assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of total antibodies to Treponema pallidum in human serum and plasma using the Access Immunoassay Systems. It is intended to be used as an aid in the diagnosis of syphilis or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection. The Access Syphilis assay is not intended for blood and tissue donor screening. FDA UDI
Model / Reference
C80411 FDA UDI
Description
The Access Syphilis assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of total antibodies to Treponema pallidum in human serum and plasma using the Access Immunoassay Systems. It is intended to be used as an aid in the diagnosis of syphilis or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection. The Access Syphilis assay is not intended for blood and tissue donor screening. FDA UDI

Identifiers

Catalog Number
C80411 FDA UDI
Primary DI / UDI-DI
15099590763626 FDA UDI
510(k) Number
K241427 FDA UDI
FDA Product Code
LIP FDA UDI
GMDN Term
Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay 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

Yes

FDA UDI

Category: Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay

Access Syphilis Reagent by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beckman Coulter, Inc.

Sources (1)

  • FDA UDI 7ef0b4d3-fbec-4bf6-b2d1-61a9d968dbcf 35 fields · synced Jun 8, 2026