FDA.reportPublic FDA data

Molecular Testing Labs

Primary DI
00860008357878
Brand
Molecular Testing Labs
Company
Blackfly Investments, LLC
Model
1.0
Device description
Dried Blood Spot and Urine Collection Kit
Published
2023-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008357878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008357878008600083578788600083578780860008357878

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
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
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