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Pointe Scientific, Inc. CMV IgM

FDA UDI

Class II (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name
Pointe Scientific, Inc. CMV IgM FDA UDI
Generic Name
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Pointe Scientific, Inc. CMV IgM Reagent is for the qualitative detection of human IgM antibodies to cytomegalovirus (CMV) in human serum by enzyme immunoassay, to aid in the diagnosis of CMV infection. A positive result is presumptive for the detection of anti-CMV IgM antibodies and presumptive for the diagnosis of acute or recent CMV infection. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests. FDA UDI
Model / Reference
T8006-96 FDA UDI
Description
Pointe Scientific, Inc. CMV IgM Reagent is for the qualitative detection of human IgM antibodies to cytomegalovirus (CMV) in human serum by enzyme immunoassay, to aid in the diagnosis of CMV infection. A positive result is presumptive for the detection of anti-CMV IgM antibodies and presumptive for the diagnosis of acute or recent CMV infection. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests. FDA UDI

Identifiers

Catalog Number
T8006-96 FDA UDI
Primary DI / UDI-DI
00811727015204 FDA UDI
510(k) Number
K982485 FDA UDI
FDA Product Code
LFZ FDA UDI
GMDN Term
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3175 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

No

FDA UDI

Category: Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Pointe Scientific, Inc. CMV IgM by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K982485 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pointe Scientific, Inc.

Sources (1)

  • FDA UDI 478fbfad-9cad-4f9d-a451-a943dee756a2 37 fields · synced May 31, 2026