FDA.reportPublic FDA data

RealTime

Primary DI
00884999047792
Brand
RealTime
Company
ABBOTT MOLECULAR INC.
Model
08N90-006
Catalog number
08N90-006
Device description
Abbott RealTime IDH1m2000rt Application CD-ROM
Published
2018-08-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWDSomatic gene mutation detection system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWDSomatic Gene Mutation Detection SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P170041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P170041000Abbott RealTime IDH1Abbott Molecular, Inc.2018-07-20OWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999047792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999047792008849990477928849990477920884999047792

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDA software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)553-7042customerservice@abbottmolecular.com

Regulatory Flags#

DUNS number
878263359
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884999051287Alinity m09N15-03B09N15-03B2026-04-13
00884999051690simpli-COLLECT09R16-00109R16-0012026-04-13
00884999052062Alinity m09N61-03B09N61-03B2025-11-20
00884999047846Alinity m09N26-00109N26-0012020-04-29
00884999047853Alinity m09N26-00209N26-0022020-04-29
00884999047860Alinity m09N26-01009N26-0102020-04-29
00884999047426Alinity m09N26-01209N26-0122020-04-29
00884999047440Alinity m09N26-01409N26-0142020-04-29
00884999047464Alinity m09N26-01609N26-0162020-04-29
00884999047501Alinity m09N26-00409N26-0042020-04-29
00884999048096Alinity m09N26-01909N26-0192020-04-29
00884999048171Alinity m09N26-02009N26-0202020-04-29
00884999048034Alinity m08N53-00208N53-0022020-08-18
00884999031814m20009K15-019K15-012016-09-01
00884999049369Alinity m09N79-09509N79-0952025-06-27
00884999049376Alinity m09N79-08509N79-0852025-06-27
00884999049383Alinity m09N79-03A09N79-03A2025-06-27
00884999051348simpli-COLLECT09R02-00109R02-0012025-06-26
00884999051409simpli-COLLECT09N93-00109N93-0012025-06-26
30884999051349simpli-COLLECT09R02-00109R02-0012025-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053228034834therascreen® PDGFRA RGQ PCR KitQIAGEN GmbHOWD2024-12-10
00810022732571LeukoStratINVIVOSCRIBE, INC.OWD2023-05-30
04053228043560therascreen® FGFR RGQ RT-PCR KitQIAGEN GmbHOWD2022-05-23
00054749005505i-STATABBOTT POINT OF CARE INC.OWD2020-10-05
00875197005592cobas&#x00AE EZH2 Mutation TestRoche Molecular Systems, Inc.OWD2020-08-01
00054749005123i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005147i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005154i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005161i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005178i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005185i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005192i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005208i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005215i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005222i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005529i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
04053228035725therascreen® BRAF RGQ PCR KitQIAGEN GmbHOWD2020-06-11
00850052003739LeukoStratINVIVOSCRIBE, INC.OWD2020-06-08
00850052003685LeukoStratINVIVOSCRIBE, INC.OWD2020-05-29
00054749005512i-STATABBOTT POINT OF CARE INC.OWD2020-05-01
00054749005093i-STATABBOTT POINT OF CARE INC.OWD2019-12-20
04053228034223therascreen® PIK3CA RGQ PCR KitQIAGEN GmbHOWD2019-06-05
04053228034094therascreen® FGFR RGQ RT-PCR KitQIAGEN GmbHOWD2019-04-29
00884999047341RealTimeABBOTT MOLECULAR INC.OWD2018-07-30
00884999047358RealTimeABBOTT MOLECULAR INC.OWD2018-07-30
00884999047037RealTimeABBOTT MOLECULAR INC.OWD2017-08-11
00884999047044RealTimeABBOTT MOLECULAR INC.OWD2017-08-11
00884999047051RealTimeABBOTT MOLECULAR INC.OWD2017-08-11
03573026559823THxID™ BRAFBIOMERIEUX SAOWD2017-05-12
04053228002048therascreen® KRAS RGQ PCR KitQIAGEN GmbHOWD2017-01-04