Anti-CMV IgG SM9Z9501G

GUDID 00845533003056

The Anti-CMV IgG is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV.

ZEUS SCIENTIFIC, INC.

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00845533003056
NIH Device Record Keyd0442d28-98fe-4bf5-aecc-670e673fd018
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-CMV IgG
Version Model NumberSM9Z9501G
Catalog NumberSM9Z9501G
Company DUNS080953946
Company NameZEUS SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100845533003056 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-26
Device Publish Date2026-02-18

On-Brand Devices [Anti-CMV IgG]

00845533003056The Anti-CMV IgG is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection o
00845533003049The Anti-CMV IgG is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection o

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