FDA.reportPublic FDA data

RealTime

Primary DI
00884999045774
Brand
RealTime
Company
ABBOTT MOLECULAR INC.
Model
09N21-070
Catalog number
09N21-070
Device description
Abbott RealTime CMV Calibrator Kit
Published
2017-06-06
Public version status
Update
Distribution status
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
PABCytomegalovirus (cmv) dna quantitative assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PABCytomegalovirus (Cmv) Dna Quantitative AssayMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160044000
P160044001
P160044002

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160044000ABBOTT REALTIME CMVAbbott Molecular2017-05-18PAB
P160044001ABBOTT REALTIME CMVAbbott Molecular2017-05-18PAB
P160044002ABBOTT REALTIME CMVAbbott Molecular2017-05-18PAB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999045774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999045774008849990457748849990457740884999045774

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) nucleic acid IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from cytomegalovirus (CMV) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius

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
Expiration date on label
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
00884999051065Alinity mABBOTT MOLECULAR INC.PAB2024-02-22
15420045514553Aptima®Hologic, Inc.PAB2022-06-01
15420045514560Aptima®Hologic, Inc.PAB2022-06-01
15420045514577Aptima®Hologic, Inc.PAB2022-06-01
15420045514584Aptima®Hologic, Inc.PAB2022-06-01
00884999049598Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00884999049604Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00884999049611Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00884999049956Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00875197006421cobas® CMVRoche Molecular Systems, Inc.PAB2021-12-10
00875197006490cobas® CMV Control KitRoche Molecular Systems, Inc.PAB2021-12-10
04053228024538artus® CMV QS-RGQ MDx KitQIAGEN GmbHPAB2018-05-04
00875197004922cobas CMVRoche Molecular Systems, Inc.PAB2017-07-06
00875197004939cobas CMV Control KitRoche Molecular Systems, Inc.PAB2017-07-06
00884999045781RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999045798RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999047297RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999046603RealTimeABBOTT MOLECULAR INC.PAB2017-04-17
04053228002086artus® CMV RGQ MDx KitQIAGEN GmbHPAB2017-01-04
00875197002584COBAS® AmpliPrep/ COBAS® TaqMan® CMV TestRoche Molecular Systems, Inc.PAB2014-09-10