FDA.report

Premium Heart Health + Cholesterol Test

Primary DI
00810040821202
Brand
Premium Heart Health + Cholesterol Test
Company
Cue Health Inc.
Model
C2256
Device description
Cue Sample Collection Kit, Blood (Adx Dual), Premium Heart Health + Cholesterol Test
Published
2024-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)

Product Code Classifications

CodeDeviceSpecialtyClass
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)Clinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810040821202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040821202008100408212028100408212020810040821202

GMDN Terms

TermDefinition
Capillary blood collection kit IVDA collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
081257070
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 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
00810040820977Colon Cancer Screening TestC22352024-02-12
00810040821073Herpes TestC22312024-02-12
00810040821097Heart Health + Metabolic TestC22482024-02-12
00810040820595Cue Sample Collection Kit C00262023-02-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50885380211223Aero-MedAERO-MED, LLCPQD2026-03-20
00850070635158KIT, BLOOD CULTURE COLLECTINGNar Medical Depot, LLCPQD2026-03-19
50810010894880Aero-MedAERO-MED, LLCPQD2026-03-17
00810010894960Aero-MedAERO-MED, LLCPQD2026-03-17
00850066710272Simple HealthKitSIMPLE HEALTHKIT, INC.PQD2026-01-21
04779054721198RDA SpotRDA SPOT, UABPQD2026-01-15
00850015884368easycareSynchronis Medical, LLCPQD2026-01-07
04779054721129RDA SpotRDA SPOT, UABPQD2025-11-20
04779054721143RDA SpotRDA SPOT, UABPQD2025-11-20
04779054721013ZinzinoRDA SPOT, UABPQD2025-07-24
00810111410045LetsGetChecked Blood Sample Collection Kit (LIPP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2025-07-07
00810111410281LetsGetChecked Blood Sample Collection Kit (PRGS)PRIVAPATH DIAGNOSTICS LIMITEDPQD2025-07-07
00810111410335LetsGetChecked Blood Sample Collection Kit (TSTS)PRIVAPATH DIAGNOSTICS LIMITEDPQD2025-07-07
G7327021Everlywell Blood and Urine Collection KitEverly Health, Inc.PQD2025-02-18
G7321001Everlywell Blood Collection KitEverly Health, Inc.PQD2025-02-14
G7321011Everlywell Blood Collection KitEverly Health, Inc.PQD2025-02-14
G7321021Everlywell Blood Collection KitEverly Health, Inc.PQD2025-02-14
G7321031Everlywell Blood Collection KitEverly Health, Inc.PQD2025-02-14
G7321041Everlywell Blood Collection KitEverly Health, Inc.PQD2025-02-14
G7321061Everlywell Blood Collection KitEverly Health, Inc.PQD2025-02-14
G7321071Everlywell Blood Collection KitEverly Health, Inc.PQD2025-02-14
G7321081Everlywell Blood Collection KitEverly Health, Inc.PQD2025-02-14
G7321091Everlywell Blood Collection KitEverly Health, Inc.PQD2025-02-14
G7322001Everlywell Blood Collection KitEverly Health, Inc.PQD2025-02-14
G7322011Everlywell Blood Collection KitEverly Health, Inc.PQD2025-02-14
G7322021Everlywell Blood Collection KitEverly Health, Inc.PQD2025-02-14
G7327001Everlywell Blood and Saliva Collection KitEverly Health, Inc.PQD2025-02-14
G7327031Everlywell Blood and Saliva Collection KitEverly Health, Inc.PQD2025-02-14
04779054720122ZinzinoRDA SPOT, UABPQD2024-12-27
04779054720412ZinzinoRDA SPOT, UABPQD2024-12-27