Primary Device ID | 00858637005000 |
NIH Device Record Key | 47bfacd7-64d3-49fc-a101-f8a2ea1facb1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cologuard DNA Capture Reagents |
Version Model Number | 100028 |
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 | false |
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 | 00858637005000 [Primary] |
PHP | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2014-11-17 |
00850057859003 - CG2 CAP BDS | 2025-02-27 Magnetic particles with covalently bound oligonucleotide probes (400 mL x 20 ea) |
00850057859010 - CG2 CAP WSH | 2025-02-27 MOPS Buffer, NaCl (20L) |
00850057859027 - CG2 BND SLN | 2025-02-27 Binding Solution, Guanidine Hydrochloride, Citric Acid, Sodium Citrate Tribase Dihydrate (10 L) |
00850057859034 - CG2 REC BFR | 2025-02-27 Reconstitution Buffer, 10% Albumin in Tris buffered solution, antimicrobial agent (800 mL) |
00858637005918 - CG2 CNV WSH | 2025-02-27 Conversion Wash (Concentrate), Tris Buffer, Sodium Azide ( 900 mL) |
00858637005925 - CG2 WSH | 2025-02-27 Hb Bead Based Assay Wash, Phosphate Buffer with Detergent (800 mL) |
00858637005963 - DNA and LQAS Reagent SLIB Group Kit | 2025-02-27 |
00858637005970 - DNA Controls SLIB Group Kit | 2025-02-27 |