GUDID 00848838026898

REMEL, INC.

Cryptosporidium species antigen IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00848838026898
NIH Device Record Key40aed7db-f8ae-4612-a0f9-9325032c739b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberR2451020
Company DUNS065769564
Company NameREMEL, INC.
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com
Phone8002556730
EmailITechnicalSupport@remel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848838026898 [Primary]
GS100848838099786 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHJCryptosporidium Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by REMEL, INC.

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00848838058455 - Remel™ RapID™ ERIC™ (ELECTRONIC RAPID IDENTIFICATION COMPENDIUM)2024-11-21
00848838003240 - REMEL2024-11-07 Tergitol 7 Agar w/TTC 10/PK
00848838007736 - REMEL2024-11-07 Lysozyme Broth (5ml) 20/PK
00842558116419 - ACT I Transport PK/102024-08-14
00842558116426 - ACT II Transport PK/102024-08-14
00842558116433 - ACT II Dual Transport PK/102024-08-14
05032384519903 - ProSpecT2024-08-06 ProSpecT C. diff Toxin A/B MP KT/96TST

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