Monobind Qsure Anti-Tg & Anti-TPO Control Set AIT-101

GUDID 00816870020174

MONOBIND, INC.

Thyroglobulin/Thyroid peroxidase antibody (anti-TPO/Microsomal antibody) IVD, control
Primary Device ID00816870020174
NIH Device Record Key13219f31-007f-4d46-b7c8-ee12729f0e2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonobind Qsure Anti-Tg & Anti-TPO Control Set
Version Model NumberAIT-101
Catalog NumberAIT-101
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
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

Width2 Inch
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Width2 Inch
Width2 Inch
Width2 Inch
Width2 Inch
Width2 Inch
Width2 Inch
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Width2 Inch
Width2 Inch
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Width2 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816870020174 [Primary]

FDA Product Code

JJYMulti-analyte controls, all kinds (assayed)

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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