FDA.reportPublic FDA data

CVS Health At Home

Primary DI
00860008357847
Brand
CVS Health At Home
Company
Blackfly Investments, LLC
Model
STI collection kit
Catalog number
50428654200
Device description
Dry blood spot card collection kit utilizing 903 Five Spot Blood Card and Hologic Aptima Urine transport tube.
Published
2022-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LIODevice, Specimen Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIODevice, Specimen CollectionMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008357847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008357847008600083578478600083578470860008357847

GMDN Terms#

Term, Definition table
TermDefinition
Dried blood spot collection kit IVDA collection of devices and materials intended to be used by a healthcare professional at the point-of-care to collect a dried blood spot (DBS) specimen from capillary or venous blood, for subsequent diagnostic testing or screening. The kit typically includes a lancet and/or hypodermic needle with a syringe, capillary tube(s), a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
069497839
Device count
1
Kit
true
Combination product
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
00860008357816CVS Health At HomeVitamin D collection kit504286566792022-07-20
00860008357823CVS Health At HomeLyme Disease Collection Kit504286538902022-07-20
00860008357830CVS Health At HomeThyroid collection kit504286546372022-07-19

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Primary DI, Brand, Company table
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