Cologuard DNA Capture Reagents

GUDID 00858637005000

EXACT SCIENCES CORPORATION

Nucleic acid extraction/isolation kit IVD
Primary Device ID00858637005000
NIH Device Record Key47bfacd7-64d3-49fc-a101-f8a2ea1facb1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCologuard DNA Capture Reagents
Version Model Number100028
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 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858637005000 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-11-17

Devices Manufactured by EXACT SCIENCES CORPORATION

00850057859003 - CG2 CAP BDS2025-02-27 Magnetic particles with covalently bound oligonucleotide probes (400 mL x 20 ea)
00850057859010 - CG2 CAP WSH2025-02-27 MOPS Buffer, NaCl (20L)
00850057859027 - CG2 BND SLN2025-02-27 Binding Solution, Guanidine Hydrochloride, Citric Acid, Sodium Citrate Tribase Dihydrate (10 L)
00850057859034 - CG2 REC BFR2025-02-27 Reconstitution Buffer, 10% Albumin in Tris buffered solution, antimicrobial agent (800 mL)
00858637005918 - CG2 CNV WSH2025-02-27 Conversion Wash (Concentrate), Tris Buffer, Sodium Azide ( 900 mL)
00858637005925 - CG2 WSH2025-02-27 Hb Bead Based Assay Wash, Phosphate Buffer with Detergent (800 mL)
00858637005963 - DNA and LQAS Reagent SLIB Group Kit2025-02-27
00858637005970 - DNA Controls SLIB Group Kit2025-02-27

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