Monobind Qsure Tg Control Set TG-300

GUDID 00816870020198

MONOBIND, INC.

Thyroglobulin antibody IVD, control
Primary Device ID00816870020198
NIH Device Record Key5157e751-57af-4867-acd8-bdda5ba2b728
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonobind Qsure Tg Control Set
Version Model NumberTG-300
Catalog NumberTG-300
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

Width2 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816870020198 [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

Devices Manufactured by MONOBIND, INC.

00816870020594 - Monobind AccuBind Free PSA ELISA Kit - 96 Wells2020-02-06
00816870020600 - Monobind AccuBind Free PSA ELISA Kit - 192 Wells2020-02-06
00816870020617 - Monobind AccuBind PSA ELISA Kit - 96 Wells2020-02-06
00816870020624 - Monobind AccuBind PSA ELISA Kit - 192 Wells2020-02-06
00816870020631 - Monobind AccuBind PSA Extra Sensitive ELISA Kit - 96 Wells2020-02-06
00816870020648 - Monobind AccuBind PSA Extra Sensitive ELISA Kit - 192 Wells2020-02-06
00816870022277 - Monobind AccuLite Free PSA CLIA Kit - 96 Wells2020-02-06
00816870022284 - Monobind AccuLite Free PSA CLIA Kit - 192 Wells2020-02-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.