Primary Device ID | 00858637005949 |
NIH Device Record Key | d09d7ca7-e4a5-4f15-b174-79ee69c83463 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | The Cologuard Plus Collection Kit |
Version Model Number | 100676 |
Company DUNS | 150908853 |
Company Name | EXACT SCIENCES CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00858637005949 [Primary] |
PHP | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-27 |
Device Publish Date | 2025-03-19 |
00858637005840 - Analysis Server v2.2 | 2025-03-27 Exact Sciences Software System 2.2 |
00858637005857 - Analysis Client v2.2 | 2025-03-27 Exact Sciences Software System 2.2 |
00858637005864 - STARlet Interface v2.2 | 2025-03-27 Exact Sciences Software System 2.2 |
00858637005871 - Cycler Control v2.2 | 2025-03-27 Exact Sciences Software System 2.2 |
00858637005888 - Cologuard Test Definition v1.7 | 2025-03-27 |
00858637005901 - Cologuard 2 Test Definition | 2025-03-27 |
00858637005949 - The Cologuard Plus Collection Kit | 2025-03-27 |
00858637005949 - The Cologuard Plus Collection Kit | 2025-03-27 |
00850057859003 - CG2 CAP BDS | 2025-02-27 Magnetic particles with covalently bound oligonucleotide probes (400 mL x 20 ea) |