FDA.reportPublic FDA data

Everlywell Saliva Collection Kit

Primary DI
G7323001
Brand
Everlywell Saliva Collection Kit
Company
Everly Health, Inc.
Model
2
Published
2025-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
G7323001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Oral/respiratory tract specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
125739457
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G7327021Everlywell Blood and Urine Collection Kit32025-02-18
G7321001Everlywell Blood Collection Kit32025-02-14
G7321011Everlywell Blood Collection Kit32025-02-14
G7321021Everlywell Blood Collection Kit12025-02-14
G7321031Everlywell Blood Collection Kit22025-02-14
G7321041Everlywell Blood Collection Kit22025-02-14
G7321061Everlywell Blood Collection Kit32025-02-14
G7321071Everlywell Blood Collection Kit32025-02-14
G7321081Everlywell Blood Collection Kit12025-02-14
G7321091Everlywell Blood Collection Kit42025-02-14
G7322001Everlywell Blood Collection Kit32025-02-14
G7322011Everlywell Blood Collection Kit32025-02-14
G7322021Everlywell Blood Collection Kit32025-02-14
G7327001Everlywell Blood and Saliva Collection Kit22025-02-14
G7327031Everlywell Blood and Saliva Collection Kit42025-02-14
G7324001Everlywell Urine Collection Kit62025-02-14
G7324011Everlywell Urine Collection Kit52025-02-14
G7326001Everlywell FIT Kit02025-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G669CNPTLN1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, Non-SterileCorramedical Inc.NNK2026-04-07
00860013988029500 Single strip cards and 500 foil-LifelineADVANCE DX, INC.NNK2026-03-03
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
00827989007772Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007789Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007796Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
B24280EZEX21000Easy 2 Stool Extraction DeviceAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NNK2025-10-30
00810185250004TherapakTherapak LLCNNK2025-08-11
00810185250042TherapakTherapak LLCNNK2025-08-11
00810185250202TherapakTherapak LLCNNK2025-08-11
00810185250349TherapakTherapak LLCNNK2025-08-11
00810185250608TherapakTherapak LLCNNK2025-08-11
00810185250646TherapakTherapak LLCNNK2025-08-11
00810185250561TherapakTherapak LLCNNK2025-08-04
00810185250622TherapakTherapak LLCNNK2025-08-04
00840216128729QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
00840216128736QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
04038917086318Urine receptacle 500mlSarstedt Aktiengesellschaft & Co.KGNNK2025-05-19
00860013899264Paternity Test Kit 50Ditek Consulting, LLCNNK2025-05-06
00860013899288Paternity Test Kit 25Ditek Consulting, LLCNNK2025-05-06
00860011770268Covid 19 Testing KitDitek Consulting, LLCNNK2025-05-01
00613647027059FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027066FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027073FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027080FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30