D CAL 1 Kit

GUDID 00858637005451

EXACT SCIENCES CORPORATION

Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD
Primary Device ID00858637005451
NIH Device Record Keyf3d52819-29e0-4452-acc1-c47c441271af
Commercial Distribution StatusIn Commercial Distribution
Brand NameD CAL 1 Kit
Version Model Number100304
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
GS100858637005451 [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

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00858637005437 - D CTRL 2 Kit2021-09-06
00858637005444 - D CTRL 3 Kit2021-09-06
00858637005451 - D CAL 1 Kit2021-09-06
00858637005451 - D CAL 1 Kit2021-09-06
00858637005468 - D CAL 2 Kit2021-09-06
00858637005475 - D CAL 3 Kit2021-09-06

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