AccuDiag™ FSH ELISA 4224-15

GUDID 00850054026705

AccuDiag™ FSH ELISA

Diagnostic Automation, Inc.

Follicle stimulating hormone (FSH) IVD, kit, radioimmunoassay
Primary Device ID00850054026705
NIH Device Record Key67e543d1-05b3-4527-9e48-a20651747669
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuDiag™ FSH ELISA
Version Model NumberDACD4224-15
Catalog Number4224-15
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

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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850054026705 [Primary]

FDA Product Code

CGJRadioimmunoassay, Follicle-Stimulating Hormone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-04
Device Publish Date2026-01-27

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Trademark Results [AccuDiag]

Mark Image

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

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