FDA.reportPublic FDA data

Cytomegalovirus IgG 120 Tests

Primary DI
00813545025489
Brand
Cytomegalovirus IgG 120 Tests
Company
SCIMEDX CORPORATION
Model
I-CMV01G
Catalog number
I-CMV01G
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GQHAntigen, Cf (Including Cf Control), Cytomegalovirus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQHAntigen, Cf (Including Cf Control), CytomegalovirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K882835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K882835000INDIRECT FLUORESCENT ASSAY FOR (HCMV)Stellar Bio Systems, Inc.1988-12-05GQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813545025489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545025489008135450254898135450254890813545025489

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) immunoglobulin G (IgG) 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 G (IgG) antibodies to cytomegalovirus (CMV) in a clinical specimen, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002215598service@scimedx.com

Regulatory Flags#

DUNS number
155424708
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813545026905MeDiCa1001-481001-482020-11-04
00813545026912MeDiCa1001-961001-962020-11-04
00813545026561MeDiCa010101012020-12-01
00813545026578MeDiCa010201022020-12-01
00813545026776MeDiCa082108212020-12-01
00813545026783MeDiCa082208222020-12-01
00813545026790MeDiCa0821-M0821-M2020-12-01
00813545026806MeDiCa0822-M0822-M2020-12-01
00813545026813MeDiCa083108312020-12-01
00813545026820MeDiCa083208322020-12-01
00813545026837MeDiCa0831-M0831-M2020-12-01
00813545026844MeDiCa0832-M0832-M2020-12-01
00813545026851MeDiCa083308332020-12-01
00813545026868MeDiCa0833-M0833-M2020-12-01
00813545026875MeDiCa083408342020-12-01
00813545026882MeDiCa0834-M0834-M2020-12-01
00813545026899MeDiCa0842-RM0842-M2020-12-01
00813545027223MeDiCa8021-488021-482020-12-01
00813545027261MeDiCa8021-4008021-4002020-12-01
00813545027278MeDiCa8021-96-GI8021-96-GI2020-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G5229021111Cytomegalovirus / CMV IgG IFA 96 TestHemagen Diagnostics, Inc.GQH2023-10-06
G5229021121Cytomegalovirus / CMV IgM IFA 96 TestHemagen Diagnostics, Inc.GQH2023-10-06
04053252589768Light Diagnostics CMV Control Slides (5 pack)EMD Millipore CorporationGQH2020-04-17
04053252671074Light Diagnostics CMV IFA ReagentEMD Millipore CorporationGQH2020-04-17
04053252731730Light Diagnostics Anti-mouse IGG:FITCEMD Millipore CorporationGQH2020-04-17
04053252737183Light Diagnostics Mouse Anti-CMV Monoclonal AntibodyEMD Millipore CorporationGQH2020-04-17
04061841047445Light Diagnostics CMV Control SlideEMD Millipore CorporationGQH2020-04-17
03573026390273ARGENE® CINAkit HCMV ppUL83 USBIOMERIEUX SAGQH2016-10-17
04053252676024Light Diagnostics™ CMV IFA KitEMD Millipore CorporationGQH2016-09-26
00813545025502Cytomegalovirus 10wl/10 pk SCIMEDX CORPORATIONGQH2016-09-20
B110CM20120Cytomegalovirus Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.GQH2016-09-12
B110CMG1200CMV IgG Test System, 120 TestsBion Enterprises, Ltd.GQH2016-09-12
B110CMG20200CMV IgG ControlBion Enterprises, Ltd.GQH2016-09-12
B110CMM20300CMV IgM ControlBion Enterprises, Ltd.GQH2016-09-12
B110CMN20100CMV Negative ControlBion Enterprises, Ltd.GQH2016-09-12