Monobind AccuLite T4 CLIA Kit - 960 Wells 275-300E

GUDID 00816870023120

MONOBIND, INC.

Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
Primary Device ID00816870023120
NIH Device Record Keybb042bd2-c452-4f4a-b1a2-eb13eb5920e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonobind AccuLite T4 CLIA Kit - 960 Wells
Version Model Number275-300
Catalog Number275-300E
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

Width12 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100816870023120 [Primary]

FDA Product Code

CDXRadioimmunoassay, total thyroxine

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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00816870022284 - Monobind AccuLite Free PSA CLIA Kit - 192 Wells2020-02-06

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