FDA.reportPublic FDA data

ISOLATOR™ 1.5 mL Microbial Tubes

Primary DI
10811877010958
Brand
ISOLATOR™ 1.5 mL Microbial Tubes
Company
Alere Scarborough, Inc.
Model
50C5
Device description
The ISOLATOR 1.5 mL microbial tube is intended for use in the collection of small volume pediatric blood samples to be used in the isolation of microorganisms.
Published
2020-10-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LIODevice, Specimen Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIODevice, Specimen CollectionMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K832246000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K832246000DUPONT ISOLATOR 1.5 MICROBIAL TUBEE.I. Dupont DE Nemours & Co., Inc.1983-09-26LIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877010958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701095810811877010958

GMDN Terms#

Term, Definition table
TermDefinition
Blood cell lysis reagent IVDA substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154148498
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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