FDA.reportPublic FDA data

Cytomegalovirus (CMV) IgMm

Primary DI
00845533003650
Brand
Cytomegalovirus (CMV) IgMm
Company
ZEUS SCIENTIFIC, INC.
Model
FA9001M
Catalog number
FA9001M
Device description
The Cytomegalovirus (CMV) IgM Test System is designed for qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum. The Test System is intended to be used to evaluate serologic evidence of primary or reactivated infection with CMV and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
Published
2026-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845533003650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533003650008455330036508455330036500845533003650

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to cytomegalovirus (CMV) in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
080953946
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845533003681Herpes Simplex Virus-1 (HSV-1) IgMFA9051MFA9051M2026-06-09
00845533003698Herpes Simplex Virus-2 (HSV-2) IgGFA9052GFA9052G2026-06-09
00845533003582Alegria Flash SSA-60CL28001CL280012026-06-08
00845533003599Alegria Flash SSA-60 Control KitCL28001CKCL28001CK2026-06-08
00845533003605Alegria Flash SSA-52CL28011CL280112026-06-08
00845533003612Alegria Flash SSA-52 Control KitCL28011CKCL28011CK2026-06-08
00845533003629Alegria Flash SSBCL28021CL280212026-06-08
00845533003636Alegria Flash SSB Control KitCL28021CKCL28021CK2026-06-08
00845533003643Cytomegalovirus (CMV) IgGFA9001GFA9001G2026-06-08
00845533003667Herpes Simplex Virus-1 (HSV-1) IgGFA9051GFA9051G2026-06-08
00845533003674Herpes Simplex Virus-2 (HSV-2) IgMFA9052MFA9052M2026-06-08
00845533003551Legionella pneumophila (Group 1-6)FA15001FA150012026-05-26
00845533003568Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgGFA9151GFA9151G2026-05-26
00845533003575Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgMFA9151MFA9151M2026-05-26
00845533003483Striated Muscle (Rat)5848RL5848RL2026-05-15
00845533003490Alegria Flash PR3CL28141CL281412026-05-15
00845533003506Alegria Flash PR3 Control KitCL28141CKCL28141CK2026-05-15
00845533003513Alegria Flash MPO CL28131CL281312026-05-15
00845533003520Alegria Flash MPO Control KitCL28131CKCL28131CK2026-05-15
00845533003537Alegria Flash GBM CL28151CL281512026-05-15