FDA.reportPublic FDA data

ISOLATOR™ 10 mL Microbial Tubes

Primary DI
10811877010965
Brand
ISOLATOR™ 10 mL Microbial Tubes
Company
Alere Scarborough, Inc.
Model
50C7
Device description
The ISOLATOR™ 10 mL Microbial Tubes is intended for use in the collection and concentration of mircroorganisms from the blood.
Published
2016-09-05
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
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K810664000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K810664000ISOLATOR SYSTEME.I. Dupont DE Nemours & Co., Inc.1981-03-31JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877010965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701096510811877010965

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10811877010064ISOSTAT® Consumables50C92016-09-05
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00811877012221BinaxNOW COVID-19/Flu A&B Combo Self Test200023512026-05-06
10811877011245WOUNDCHEK™ Bacterial Status360006US2020-05-26
00811877012153ID NOW InstrumentNAT-024R2025-08-01
00811877011477BinaxNOW COVID-19 Antigen Self Test195-1402023-09-05
00811877011118BinaxNOW COVID-19 Antigen Self Test195-1702023-08-11
00811877011729BinaxNOW COVID-19 Antigen Self Test195-1802022-10-03
00811877011408BinaxNOW COVID-19 Antigen Self Test195-1602021-04-21
10811877010934Osteomark NTx Urine90062020-09-16
10811877010941Osteomark NTx Serum90212020-09-16
00811877010050ISOSTAT® Press and Rack50C22016-09-05
00811877010098ISOSTAT® Containment Adapter50C12016-09-03
00811877012030BinaxNOW COVID-19/Flu A&B Combo Self Test20002050 2025-01-30
00811877012047BinaxNOW COVID-19/Flu A&B Combo Self Test20002056 2025-01-30
00811877012054BinaxNOW COVID-19/Flu A&B Combo Self Test200020512025-01-30
00811877012061BinaxNOW COVID-19/Flu A&B Combo Self Test20002057 2025-01-30
00811877012078BinaxNOW COVID-19/Flu A&B Combo Self Test20002052 2025-01-30
00811877012085BinaxNOW COVID-19/Flu A&B Combo Self Test20002058 2025-01-30
00811877012092BinaxNOW COVID-19/Flu A&B 20002054 2025-01-30

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