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Access Syphilis Calibrators

FDA UDI

Class II (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name
Access Syphilis Calibrators FDA UDI
Generic Name
Treponema pallidum total antibody IVD, calibrator FDA UDI
Device Name
The Access Syphilis Calibrators are used to establish calibration (determine the cut-off value) for the Access Syphilis assay. By comparing the light intensity generated by a sample to the cut-off value, the presence or absence of Treponema pallidum antibodies in the sample is determined. FDA UDI
Model / Reference
C80412 FDA UDI
Description
The Access Syphilis Calibrators are used to establish calibration (determine the cut-off value) for the Access Syphilis assay. By comparing the light intensity generated by a sample to the cut-off value, the presence or absence of Treponema pallidum antibodies in the sample is determined. FDA UDI

Identifiers

Catalog Number
C80412 FDA UDI
Primary DI / UDI-DI
15099590763633 FDA UDI
FDA Product Code
JIT FDA UDI
GMDN Term
Treponema pallidum total antibody IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 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

Yes

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, calibrator

Access Syphilis Calibrators 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, calibrator.

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 402ed24d-4f5f-4e2e-8f2c-22792daa26e5 34 fields · synced Jun 8, 2026