FDA.reportPublic FDA data

CVS Health At Home

Primary DI
00860008357830
Brand
CVS Health At Home
Company
Blackfly Investments, LLC
Model
Thyroid collection kit
Catalog number
50428654637
Device description
Dry blood spot collection kit using 903 Five Spot Blood card
Published
2022-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008357830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008357830008600083578308600083578300860008357830

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection paperA non-sterile filter-paper card intended to be used as a medium for the collection and transport of blood specimen spots to a laboratory for testing. It provides a uniform surface for the collection of blood spot specimens taken from the patient. Also known as an Ahlstrom 226 specimen collection paper or a Whatman body fluid collection paper, it may incorporate a tear-apart form for demographic information. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
069497839
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850068539017Molecular Testing LabsSwab Collection Kit2024-11-13
00850068539000Molecular Testing LabsDried Blood Spot and Swab Collection Kit2024-09-18
00860008357885Molecular Testing LabsDried Blood Spot and Neat Urine Collection Kit2024-09-16
00860008357892Molecular Testing LabsDried Blood Spot, Urine, and Swab Collection Kit2024-09-16
00860008357854Molecular Testing Labs1.02023-03-29
00860008357861Molecular Testing Labs1.02023-03-29
00860008357878Molecular Testing Labs1.02023-03-29
00860008357809CVS Health At HomeFood Sensitivity collection504286540572022-07-20
00860008357847CVS Health At HomeSTI collection kit504286542002022-07-23
00860008357816CVS Health At HomeVitamin D collection kit504286566792022-07-20
00860008357823CVS Health At HomeLyme Disease Collection Kit504286538902022-07-20