NEU SLN Kit

GUDID 00858637005567

EXACT SCIENCES CORPORATION

Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD
Primary Device ID00858637005567
NIH Device Record Key8983110e-634e-4f36-8b05-2a20be9137ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEU SLN Kit
Version Model Number100315
Company DUNS150908853
Company NameEXACT SCIENCES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858637005567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-06
Device Publish Date2021-08-27

Devices Manufactured by EXACT SCIENCES CORPORATION

00858637005338 - Cologuard STL BFR2024-02-02 Stool Buffer, 1000 L
00858637005932 - Cologuard FILT2024-02-02 Spin Filter, 300 ea
00858637005420 - D CTRL 1 Kit2021-09-06
00858637005437 - D CTRL 2 Kit2021-09-06
00858637005444 - D CTRL 3 Kit2021-09-06
00858637005451 - D CAL 1 Kit2021-09-06
00858637005468 - D CAL 2 Kit2021-09-06
00858637005475 - D CAL 3 Kit2021-09-06

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