FDA.reportPublic FDA data

Molecular Testing Labs

Primary DI
00850068539000
Brand
Molecular Testing Labs
Company
Blackfly Investments, LLC
Model
Dried Blood Spot and Swab Collection Kit
Device description
Dried Blood Spot and Swab Collection Kit
Published
2024-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850068539000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850068539000008500685390008500685390000850068539000

GMDN Terms#

Term, Definition table
TermDefinition
Dried blood spot collection card IVDA device intended to be used for dried blood spot collection and preservation, at the point-of-care, for subsequent diagnostic testing or screening. It is typically in the form of paper integrated in a card, on which a whole blood specimen is applied and absorbed onto the collection paper. The card may include a form to capture patient 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
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
00860008357830CVS Health At HomeThyroid collection kit504286546372022-07-19