ihcDirect® AE1/AE3 Abs 10mL

GUDID 00850030934260

Clones AE1/AE3

NOVODIAX, INC.

Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry Cytokeratin IVD, kit, enzyme immunohistochemistry
Primary Device ID00850030934260
NIH Device Record Keyeb0886b4-150d-42a2-9b32-260f3d721148
Commercial Distribution StatusIn Commercial Distribution
Brand NameihcDirect® AE1/AE3 Abs 10mL
Version Model NumberK31007-010
Company DUNS965326957
Company NameNOVODIAX, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Phone5103423043
Emailsupport@novodiax.com
Phone5103423043
Emailsupport@novodiax.com
Phone5103423043
Emailsupport@novodiax.com
Phone5103423043
Emailsupport@novodiax.com
Phone5103423043
Emailsupport@novodiax.com
Phone5103423043
Emailsupport@novodiax.com
Phone5103423043
Emailsupport@novodiax.com
Phone5103423043
Emailsupport@novodiax.com
Phone5103423043
Emailsupport@novodiax.com

Device Dimensions

Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 21 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 21 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 21 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 21 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 21 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 21 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 21 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 21 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 21 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850030934260 [Primary]

FDA Product Code

NJTImmunohistochemistry Reagents And Kits

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-30
Device Publish Date2021-08-20

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Trademark Results [ihcDirect]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IHCDIRECT
IHCDIRECT
86565063 5124949 Live/Registered
Novodiax Inc
2015-03-16

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