FDA.reportPublic FDA data

HIV Test

Primary DI
00810040821110
Brand
HIV Test
Company
Cue Health Inc.
Model
C2249
Device description
Cue Sample Collection Kit, Blood (5 DBS), HIV 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

Product Codes#

Code, Name table
CodeName
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)Clinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040821110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040821110008100408211108100408211100810040821110

GMDN Terms#

Term, Definition table
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 table
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 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
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220803BASELINE Venous Sample Collection kitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
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