FDA.reportPublic FDA data

Colon Cancer Screening Test

Primary DI
00810040820977
Brand
Colon Cancer Screening Test
Company
Cue Health Inc.
Model
C2235
Device description
Cue Sample Collection Kit, Stool, Colon Cancer Screening Test
Published
2024-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040820977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040820977008100408209778100408209770810040820977

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen collection kit IVD, home-useA collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081257070
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810040820984Heart Health + Cholesterol TestC22242024-04-30
00810040820991Vitamin D TestC22322024-04-30
00810040821004Kidney Function TestC22362024-04-30
00810040821011Men's Health TestC22452024-04-30
00810040821028Heart Disease Risk Test: Lipoprotein a + ApoBC22252024-04-30
00810040821035Glucose + Insulin TestC22462024-04-30
00810040821103Food Sensitivity TestC22342024-04-30
00810040821059Women's Health TestC22262024-04-12
00810040821066Fertility Test for WomenC22272024-04-12
00810040821080Liver Function TestC22332024-04-12
00810040821042Celiac Disease TestC22472024-03-11
00810040821110HIV TestC22492024-03-11
00810040821127Hepatitis C TestC22502024-03-11
00810040821141Thyroid TestC22512024-03-11
00810040821158Food Allergy TestC22522024-03-11
00810040821165Indoor + Outdoor Allergy TestC22532024-03-11
00810040821202Premium Heart Health + Cholesterol TestC22562024-03-11
00810040821073Herpes TestC22312024-02-12
00810040821097Heart Health + Metabolic TestC22482024-02-12
00810040820595Cue Sample Collection Kit C22432023-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860013988036500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
00860013988043Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988050Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988067Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03
00860013988074Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00860013988098Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
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