FDA.reportPublic FDA data

Shield

Primary DI
00850002748260
Brand
Shield
Company
Guardant Health, Inc.
Model
GH10128
Published
2026-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin DetectionUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230009000ShieldGuardant Health, Inc.2024-07-26PHP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002748260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002748260008500027482608500027482600850002748260

GMDN Terms#

Term, Definition table
TermDefinition
Methylated DNA IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials (e.g., software) intended to be used for the qualitative and/or quantitative detection of methylated DNA (e.g., from cell-free DNA or circulating tumour DNA screening) in a clinical specimen. Methylated DNA and DNA methylation patterns in specific genes or genomic regions are typically associated with the development of cancer.

Regulatory Flags#

DUNS number
119012278
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002748017ShieldGH100512026-10-28
00850002748284ShieldGH101322026-10-28
00850002748307ShieldGH101452026-10-28
00850002748390ShieldGH101592026-10-28
00850002748093Guardant360 CDxGH100062026-06-07
00850002748079Guardant360 CDxGH100052026-06-04
00850002748277Guardant360 Liquid CDxGH101092026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850002748017ShieldGuardant Health, Inc.PHP2026-10-28
00850002748284ShieldGuardant Health, Inc.PHP2026-10-28
00850002748307ShieldGuardant Health, Inc.PHP2026-10-28
00850002748390ShieldGuardant Health, Inc.PHP2026-10-28
00850057859362SimpleScreen CRCEXACT SCIENCES CORPORATIONPHP2026-10-22
00850057859096Cologuard ® Collection KitEXACT SCIENCES CORPORATIONPHP2026-04-22
00858637005840Analysis Server v2.2EXACT SCIENCES CORPORATIONPHP2025-03-19
00858637005857Analysis Client v2.2EXACT SCIENCES CORPORATIONPHP2025-03-19
00858637005864STARlet Interface v2.2EXACT SCIENCES CORPORATIONPHP2025-03-19
00858637005871Cycler Control v2.2EXACT SCIENCES CORPORATIONPHP2025-03-19
00858637005888Cologuard Test Definition v1.7EXACT SCIENCES CORPORATIONPHP2025-03-19
00858637005901Cologuard 2 Test DefinitionEXACT SCIENCES CORPORATIONPHP2025-03-19
00858637005949The Cologuard Plus Collection KitEXACT SCIENCES CORPORATIONPHP2025-03-19
00850057859003CG2 CAP BDSEXACT SCIENCES CORPORATIONPHP2025-02-19
00850057859010CG2 CAP WSHEXACT SCIENCES CORPORATIONPHP2025-02-19
00850057859027CG2 BND SLNEXACT SCIENCES CORPORATIONPHP2025-02-19
00850057859034CG2 REC BFREXACT SCIENCES CORPORATIONPHP2025-02-19
00858637005918CG2 CNV WSHEXACT SCIENCES CORPORATIONPHP2025-02-19
00858637005925CG2 WSHEXACT SCIENCES CORPORATIONPHP2025-02-19
00858637005963DNA and LQAS Reagent SLIB Group KitEXACT SCIENCES CORPORATIONPHP2025-02-19
00858637005970DNA Controls SLIB Group KitEXACT SCIENCES CORPORATIONPHP2025-02-19
00858637005987Hemoglobin Bead Based Assay Reagents SLIB Group KitEXACT SCIENCES CORPORATIONPHP2025-02-19
00858637005994Hemoglobin Bead Controls SLIB Goup KitEXACT SCIENCES CORPORATIONPHP2025-02-19
00858637005345CAP SLNEXACT SCIENCES CORPORATIONPHP2024-11-20
00858637005833Reader Control v2.2EXACT SCIENCES CORPORATIONPHP2024-04-25
00858637005338Cologuard STL BFREXACT SCIENCES CORPORATIONPHP2024-01-25
00858637005932Cologuard FILTEXACT SCIENCES CORPORATIONPHP2024-01-25
00858637005420D CTRL 1 KitEXACT SCIENCES CORPORATIONPHP2021-08-27
00858637005437D CTRL 2 KitEXACT SCIENCES CORPORATIONPHP2021-08-27
00858637005444D CTRL 3 KitEXACT SCIENCES CORPORATIONPHP2021-08-27