Monobind AccuLite Tg CLIA Kit - 96 Wells 2275-300A

GUDID 00816870023205

MONOBIND, INC.

Thyroglobulin IVD, kit, chemiluminescent immunoassay
Primary Device ID00816870023205
NIH Device Record Keycda8838a-8d7f-4c49-95ee-8a2c121dd316
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonobind AccuLite Tg CLIA Kit - 96 Wells
Version Model Number2275-300
Catalog Number2275-300A
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

Device Dimensions

Width7.75 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816870023205 [Primary]

FDA Product Code

MSWSystem, test, thyroglobulin

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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