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Access SARS-CoV-2 IgM Calibrator

FDA UDI

Class N (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name
Access SARS-CoV-2 IgM Calibrator FDA UDI
Generic Name
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, calibrator FDA UDI
Device Name
The Access SARS-CoV-2 IgM Calibrators are intended to calibrate the Access SARS-CoV-2 IgM assay for the in vitro qualitative detection of SARS-CoV-2 IgM antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgM calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization. FDA UDI
Model / Reference
C58958 FDA UDI
Description
The Access SARS-CoV-2 IgM Calibrators are intended to calibrate the Access SARS-CoV-2 IgM assay for the in vitro qualitative detection of SARS-CoV-2 IgM antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgM calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization. FDA UDI

Identifiers

Catalog Number
C58958 FDA UDI
Primary DI / UDI-DI
15099590738624 FDA UDI
FDA Product Code
QKO FDA UDI
GMDN Term
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, calibrator FDA UDI

Classification

Device Class
N 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: SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, calibrator

Access SARS-CoV-2 IgM Calibrator by Beckman Coulter, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as SARS-CoV-2 immunoglobulin M (IgM) 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 cc577f49-ecc6-4867-bee9-cd6c23bf61c2 34 fields · synced Jun 8, 2026