Molecular Testing Labs

Primary DI
00860008357861
Brand
Molecular Testing Labs
Company
Blackfly Investments, LLC
Model
1.0
Device description
Stool 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
00860008357861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008357861008600083578618600083578610860008357861

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen collection kit IVD, home-useA collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical 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
00860008357878Molecular Testing Labs1.02023-03-29
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00860008357823CVS Health At HomeLyme Disease Collection Kit504286538902022-07-20
00860008357830CVS Health At HomeThyroid collection kit504286546372022-07-19