FDA.reportPublic FDA data

RealTime

Primary DI
00884999023932
Brand
RealTime
Company
ABBOTT MOLECULAR INC.
Model
6L18-80
Catalog number
6L18-80
Device description
Abbott RealTime HIV-1 Control Kit
Published
2016-07-01
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
MZFTest, hiv detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZFTest, Hiv DetectionMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BP06000213
BP06000214
BP06000216
BP06000218
BP06000221
BP06000222
BP06000225
BP06000226
BP06000227
BP06000228
BP06000229
BP06000231
BP06000232
BP06000234
BP06000236
BP06000237
BP06000238
BP06000242
BP06000244
BP06000245
BP06000246
BP06000248
BP06000249
BP06000250
BP06000252
BP06000254
BP06000255
BP06000256
BP0600026
BP0600028
BP0600029

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BP06000213
BP06000214
BP06000216
BP06000218
BP06000221
BP06000222
BP06000225
BP06000226
BP06000227
BP06000228
BP06000229
BP06000231
BP06000232
BP06000234
BP06000236
BP06000237
BP06000238
BP06000242
BP06000244
BP06000245
BP06000246
BP06000248
BP06000249
BP06000250
BP06000252
BP06000254
BP06000255
BP06000256
BP0600026
BP0600028
BP0600029

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999023932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999023932008849990239328849990239320884999023932

GMDN Terms#

Term, Definition table
TermDefinition
HIV1 nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (HIV1) nucleic acid in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0-10 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
00884999051928Alinity m09N15-03C09N15-03C2026-07-27
00884999051737RealTime09R20-00109R20-0012026-07-06
00884999051744Alinity m09R20-00209R20-0022026-07-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00875197006384cobas® HIV-1/HIV-2 QualitativeRoche Molecular Systems, Inc.MZF2025-03-31
00608337001792OraQuick HIV Self-TestOrasure Technologies, Inc.MZF2024-09-05
00608337001808OraQuick HIV Self-TestOrasure Technologies, Inc.MZF2024-09-05
00628451188186Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
00628451188193Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
00628451188209HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
10628451188213HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
10628451188220Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
10628451188237Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
10628451188244Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
10628451188251HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
10628451188268HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
00628451188179Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-10
10628451188169Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-08
15099590745158ACCESS HIV Ag/Ab comboBeckman Coulter, Inc.MZF2024-03-15
00884999050853Alinity mABBOTT MOLECULAR INC.MZF2023-06-08
07613336215845Elecsys HIV DuoRoche Diagnostics GmbHMZF2022-09-22
00884999050402Alinity mABBOTT MOLECULAR INC.MZF2022-08-29
00875197006445cobas® NHP Negative Control KitRoche Molecular Systems, Inc.MZF2022-08-01
00811877011101Determine™ HIV–1/2 Ag/Ab Combo Alere Scarborough, Inc.MZF2022-01-13
00811877011125Determine™ HIV–1/2 Ag/Ab Combo Controls Alere Scarborough, Inc.MZF2022-01-13
00875197006483cobas HIV-1/HIV-2 Qualitative Control KitRoche Molecular Systems, Inc.MZF2021-12-14
00875197006407cobas® HIV-1Roche Molecular Systems, Inc.MZF2021-12-10
00875197006476cobas® HBV/HCV/HIV-1 Control KitRoche Molecular Systems, Inc.MZF2021-12-10
07613336170182Elecsys HIV combi PTRoche Diagnostics GmbHMZF2021-09-16
07613336170212Elecsys HIV combi PTRoche Diagnostics GmbHMZF2021-09-16
00630414301280Atellica IM CHIVSiemens Healthcare Diagnostics Inc.MZF2021-01-15
00607158000083DPP HIV-SyphilisChembio Diagnostic Systems Inc.MZF2020-12-29
00686597010198INSTI HIV-1/HIV-2 Antibody TestBiolytical Laboratories IncMZF2020-09-30
00686597010303INSTI HIV-1 Control Test KitBiolytical Laboratories IncMZF2020-09-30