FDA.reportPublic FDA data

ABBOTT PRISM

Primary DI
00380740012403
Brand
ABBOTT PRISM
Company
ABBOTT LABORATORIES
Model
7B36-01
Catalog number
07B3601
Device description
ABBOTT PRISM SAMPLE CUPS
Published
2016-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZATEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZATest, Equipment, Automated Bloodborne PathogenUnknownN

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK970042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK970042000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740012403PrimaryGS10
00380740132378Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740012403003807400124033807400124030380740012403
00380740132378003807401323783807401323780380740132378

GMDN Terms#

Term, Definition table
TermDefinition
Chemiluminescent immunoassay analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
Device count
200
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336206355cobas® 6800 systemRoche Molecular Systems, Inc.MZA2026-03-26
07613336206362cobas® 8800 systemRoche Molecular Systems, Inc.MZA2026-03-26
00380740157166AlinityAbbott Ireland DiagnosticsMZA2024-07-18
00380740157173AlinityAbbott Ireland DiagnosticsMZA2024-07-18
00380740198930AlinityAbbott GmbHMZA2024-01-17
00380740162887AlinityAbbott GmbHMZA2019-11-30
00380740162863AlinityAbbott GmbHMZA2019-10-12
00380740162917AlinityAbbott GmbHMZA2019-10-12
00380740162894AlinityAbbott GmbHMZA2019-09-28
00380740162924AlinityAbbott GmbHMZA2019-09-14
00380740162931AlinityAbbott GmbHMZA2019-09-14
00380740162948AlinityAbbott GmbHMZA2019-09-14
00380740118181AlinityAbbott Ireland DiagnosticsMZA2019-07-26
00380740129613AlinityABBOTT LABORATORIESMZA2019-07-26
00380740136895AlinityAbbott Ireland DiagnosticsMZA2019-07-26
00380740138479AlinityABBOTT LABORATORIESMZA2019-07-26
00380740156817AlinityABBOTT LABORATORIESMZA2019-07-26
00380740156831AlinityABBOTT LABORATORIESMZA2018-10-03
00380740118167AlinityAbbott Ireland DiagnosticsMZA2018-05-31
00380740118174AlinityAbbott Ireland DiagnosticsMZA2018-05-31
00380740129026AlinityABBOTT LABORATORIESMZA2018-05-31
00380740132705AlinityABBOTT LABORATORIESMZA2018-05-31
00380740007904ABBOTT PRISMABBOTT LABORATORIESMZA2016-09-09
00380740007911ABBOTT PRISMABBOTT LABORATORIESMZA2016-09-09
00380740050375ABBOTT PRISMABBOTT LABORATORIESMZA2016-09-09
10758750005352ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MZA2016-08-24
10758750005420ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MZA2016-08-24
10758750005451ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MZA2016-08-24
10758750005581ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MZA2016-08-24
10758750007523ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MZA2016-08-24