AccuDiag™ 1202-2

GUDID 00894175000558

AccuDiag™ Cytomegalovirus IgM ELISA A 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 an enzyme immunoassay (EIA) method.

Diagnostic Automation, Inc.

Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00894175000558
NIH Device Record Key22334768-596d-414e-a9c7-4eeb4e25dbf9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuDiag™
Version Model NumberDACD 1202-2
Catalog Number1202-2
Company DUNS878252071
Company NameDiagnostic Automation, 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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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
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
GS100894175000558 [Primary]

FDA Product Code

LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-07
Device Publish Date2021-11-29

On-Brand Devices [AccuDiag™]

00894175000381AccuDiag™ RF Latex Test Kit For the qualitative and semi-quantitative measurement of RF in hum
00894175000312AccuDiag™CRP Latex Test Kit C- Reactive Protein (CRP) latex slide test is used for the qualita
00894175000473AccuDiag™ sTfR - Soluble Transferrin Receptor ELISA Kit A collection of reagents and other ass
00894175000527AccuDiag™Measles IgM ELISA Kit A collection of reagents and other associated materials intende
00894175000558AccuDiag™ Cytomegalovirus IgM ELISA A collection of reagents and other associated materials in
00850049545518AccuDiag™ Anti-Phospholipid Screen IgG/IgM ELISA

Trademark Results [AccuDiag]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCUDIAG
ACCUDIAG
85042566 4091726 Live/Registered
Diagnostic Automation, Inc.
2010-05-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.