FDA.reportPublic FDA data

ISOSTAT® Containment Adapter

Primary DI
00811877010098
Brand
ISOSTAT® Containment Adapter
Company
Alere Scarborough, Inc.
Model
50C1
Device description
Adapter needed for processing ISOLATOR 10 mL Microbial Tubes for Adults
Published
2016-09-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K840496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K840496000ISOSTAT MICROBIAL TUBE PROCESSINGE.I. Dupont DE Nemours & Co., Inc.1984-04-13JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811877010098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811877010098008118770100988118770100980811877010098

GMDN Terms#

Term, Definition table
TermDefinition
Centrifuge bucket/tube holderA cylindrical or bucket-like device designed as a removable component of a centrifuge rotor head intended to safely contain (hold) a laboratory test tube or centrifuge tube containing a sample/specimen while the centrifuge is being operated at high speeds. It is typically made of metal or a strong synthetic polymer, has one or multiple positions for holding the sample/specimen tubes, and is open at the proximal end for their insertion. A protective screw-top cap or lid may be included to contain the contents of one or more sample/specimen tubes in the event of breakage. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154148498
Device count
1
Kit
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10811877010064ISOSTAT® Consumables50C92016-09-05
00811877012214BinaxNOW COVID-19/Flu A&B Combo Self Test200023502026-05-06
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
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
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00811877012092BinaxNOW COVID-19/Flu A&B 20002054 2025-01-30
00811877012108BinaxNOW COVID-19/Flu A&B Controls20002055 2025-01-30

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Primary DI, Brand, Company table
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