FDA.reportPublic FDA data

Procleix

Primary DI
15420045500709
Brand
Procleix
Company
Hologic, Inc.
Model
Procleix System Fluid Preservative
Catalog number
301175
Published
2014-08-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
BK060021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK060021000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045500709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550070915420045500709

GMDN Terms#

Term, Definition table
TermDefinition
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (HIV1) nucleic acid, Hepatitis C virus nucleic acid and/or Hepatitis B virus nucleic acid in a clinical specimen, using a nucleic acid technique (NAT).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
050579217
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05420045503888SecurMarkSMARK-U-SS1SMARK-U-SS12015-09-04
05420045503895SecurMarkSMARK-U-SS2SMARK-U-SS22015-09-04
05420045503901SecurMarkSMARK-U-SS3SMARK-U-SS32015-09-04
15420045511859Unifi WorkspaceUnifi Workspace V1.02019-08-09
15420045515307Acessa ProVu System710071002023-05-16
15420045515314Acessa ProVu SystemMS-06-0171MS-06-01712023-05-16
15420045515284Acessa ProVu System520052002022-11-08
15420045513983BioZorbF0202F02022021-04-21
15420045513990BioZorbF0203F02032021-04-21
15420045514003BioZorbF0303F03032021-04-21
15420045514010BioZorbF0304F03042021-04-21
15420045514027BioZorbF0221F02212021-04-21
15420045514034BioZorbF0231F02312021-04-21
15420045514041BioZorbF0331F03312021-04-21
15420045514058BioZorbF0404F04042021-04-21
15420045514065BioZorbF0405F04052021-04-21
15420045512634Unifi WorkspaceUnifi Workspace V1.02020-09-21
15420045500020Selenia Dimensions C-View SoftwareC-ViewSW-030522014-09-05
15420045504561ATEC IntroducerAI090920AI0909202016-08-11
15420045504578ATEC IntroducerAI091220AI0912202016-08-11

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
00380740012403ABBOTT 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