FDA.reportPublic FDA data

RealTime

Primary DI
00884999036147
Brand
RealTime
Company
ABBOTT MOLECULAR INC.
Model
08L21-80
Catalog number
08L21-80
Device description
Abbott RealTime HCV Genotype II Control Kit
Published
2014-11-20
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
OBFAssay, genotyping, hepatitis c virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBFAssay, Genotyping, Hepatitis C VirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120012001
P120012002
P120012003
P120012004
P120012005
P120012006
P120012007
P120012009
P120012010
P120012011
P120012012
P120012013
P120012014
P120012015
P120012016
P120012017
P120012018

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120012001ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012002ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012003ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012004ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012005ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012006ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012007ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012009ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012010ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012011ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012012ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012013ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012014ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012015ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012016ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012017ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF
P120012018ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)Abbott Molecular2013-06-20OBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999036147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999036147008849990361478849990361470884999036147

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis C virus genotyping IVD, controlA material which is used to verify the performance of an assay intended to be used for the genotype determination of Hepatitis C virus 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
05414470156870LiRAS for LiPA HCV v1Fujirebio EuropeOBF2025-05-30
05414470816590INNO-LiPA HCV 2.0 GenotypingFujirebio EuropeOBF2025-05-30
05414470816606INNO-LiPA HCV 2.0 AmpFujirebio EuropeOBF2025-05-30
05414470816613INNO-LiPA HCV 2.0 ControlFujirebio EuropeOBF2025-05-30
05414470816620INNO-LiPA HCV 2.0 GenotypingFujirebio EuropeOBF2025-05-30
05414470816637INNO-LiPA HCV 2.0 AmpFujirebio EuropeOBF2025-05-30
00884999037472RealTimeABBOTT MOLECULAR INC.OBF2017-12-15
00630414000497VERSANT HCV 2.0 LiPASiemens Healthcare Diagnostics Inc.OBF2017-09-15
00630414000503VERSANT HCV 2.0 LiPASiemens Healthcare Diagnostics Inc.OBF2017-09-15
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)Siemens Healthcare Diagnostics Inc.OBF2017-09-15
00630414000534VERSANTSiemens Healthcare Diagnostics Inc.OBF2017-09-15
00630414602875VERSANT HCV 2.0 LiPASiemens Healthcare Diagnostics Inc.OBF2017-09-15
00630414602882VERSANT HCV 2.0 LiPASiemens Healthcare Diagnostics Inc.OBF2017-09-15
00884999042513RealTimeABBOTT MOLECULAR INC.OBF2016-09-01
00884999034266RealTimeABBOTT MOLECULAR INC.OBF2014-11-20
00884999036130RealTimeABBOTT MOLECULAR INC.OBF2014-11-20
00884999036444RealTimeABBOTT MOLECULAR INC.OBF2014-11-20