GUDID 00848838026904

REMEL, INC.

Cryptosporidium species antigen IVD, control
Primary Device ID00848838026904
NIH Device Record Key279e753d-8a20-43cf-904d-4a53bbd6464d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberR2451030
Company DUNS065769564
Company NameREMEL, 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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100848838026904 [Primary]

FDA Product Code

MHJCryptosporidium Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

Devices Manufactured by REMEL, INC.

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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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