FDA.reportPublic FDA data

RealTime

Primary DI
00884999003071
Brand
RealTime
Company
ABBOTT MOLECULAR INC.
Model
2N40-90
Catalog number
2N40-90
Device description
Abbott RealTime HBV Amplification Reagent 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
MKTHepatitis Viral B DNA Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKTHepatitis Viral B Dna DetectionMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999003071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999003071008849990030718849990030710884999003071

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus core 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 Hepatitis B virus core nucleic acid in a clinical specimen, using a nucleic acid technique (NAT).

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
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
00884999050808Alinity mABBOTT MOLECULAR INC.MKT2023-08-30
00875197006414cobas® HBVRoche Molecular Systems, Inc.MKT2021-12-10
00884999047754Alinity mABBOTT MOLECULAR INC.MKT2020-09-23
00884999047808Alinity mABBOTT MOLECULAR INC.MKT2020-09-23
00884999047815Alinity mABBOTT MOLECULAR INC.MKT2020-09-23
00884999048645Alinity mABBOTT MOLECULAR INC.MKT2020-09-23
15420045506749Aptima®Hologic, Inc.MKT2018-01-30
15420045506756Aptima®Hologic, Inc.MKT2018-01-30
15420045506763Aptima®Hologic, Inc.MKT2018-01-30
15420045506770Aptima®Hologic, Inc.MKT2018-01-30
00884999042667RealTimeABBOTT MOLECULAR INC.MKT2016-07-28
00875197004717cobas® HIV1 Quantitative nucleic acid test for use on the cobas® 68 88 SystemsRoche Diagnostics GmbHMKT2016-02-26
00875197004885cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 SystemRoche Diagnostics GmbHMKT2015-12-04
00884999003057RealTimeABBOTT MOLECULAR INC.MKT2014-11-20
00884999003064RealTimeABBOTT MOLECULAR INC.MKT2014-11-20
00884999037762RealTimeABBOTT MOLECULAR INC.MKT2014-11-20
00884999038462RealTimeABBOTT MOLECULAR INC.MKT2014-11-20
04015630936557DOCKING STATION SHORTRoche Molecular Systems, Inc.MKT2014-09-19
04038377020556High Pure System Viral Nucleic Acid KitRoche Molecular Systems, Inc.MKT2014-09-10
00875197002003COBAS® TaqMan® HBV Test, For Use With The High Pure SystemRoche Molecular Systems, Inc.MKT2014-09-10
00875197002034COBAS® AmpliPrep / COBAS® TaqMan® Wash ReagentRoche Molecular Systems, Inc.MKT2014-09-10
00875197002706COBAS® AmpliPrep / COBAS® TaqMan® HBV Test, v2.0Roche Molecular Systems, Inc.MKT2014-09-09