Monobind AccuLite DHEA CLIA Kit - 192 Wells 7475-300B

GUDID 00816870022802

MONOBIND, INC.

Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00816870022802
NIH Device Record Key56a1e04b-5105-41f1-be85-42724d27d508
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonobind AccuLite DHEA CLIA Kit - 192 Wells
Version Model Number7475-300
Catalog Number7475-300B
Company DUNS083155515
Company NameMONOBIND, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com

Device Dimensions

Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch

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
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
GS100816870022802 [Primary]

FDA Product Code

JKCRADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-11

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