FDA.reportPublic FDA data

PreciControl Anti-HAV II

Primary DI
07613336129746
Brand
PreciControl Anti-HAV II
Company
Roche Diagnostics GmbH
Model
08086672190
Catalog number
08086672190
Published
2019-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QCHAssayed quality control material for clinical microbiology assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCHAssayed Quality Control Material For Clinical Microbiology AssaysMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190428000Elecsys Anti-HAV IIRoche Diagnostics2019-08-13LOL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336129746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336129746076133361297467613336129746

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis A virus immunoglobulin M (IgM) antibody 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 immunoglobulin M (IgM) antibodies to the Hepatitis A virus in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05391523442251Multichem ID-HIV p24 Mini KitTECHNO-PATH MANUFACTURING LIMITEDQCH2026-05-01
05391523442435Multichem ID-HIV p24 TECHNO-PATH MANUFACTURING LIMITEDQCH2026-05-01
15099590806453Access anti-HAV IgM CalibratorBeckman Coulter, Inc.QCH2026-04-23
00380740197643AlinityAbbott GmbHQCH2023-11-04
00380740174347AlinityAbbott GmbHQCH2022-11-26
08056771602976LIAISON MeMed BV Control SetDiasorin Inc.QCH2022-08-10
00630414607054DV/DM COV2G/CV2G POS/NEG CTRLSiemens Healthcare Diagnostics Inc.QCH2021-01-22
00630414298405DV/DM COV2G/CV2G POS/NEG CTRLSiemens Healthcare Diagnostics Inc.QCH2021-01-22
00630414247014ADVIA Centaur Zika IgM QCSiemens Healthcare Diagnostics Inc.QCH2020-02-24
00630414247038ADVIA Centaur Zika Ab QCSiemens Healthcare Diagnostics Inc.QCH2020-02-24
00630414286846Atellica IM Zika IgM ControlsSiemens Healthcare Diagnostics Inc.QCH2020-02-24
00630414286860Atellica IM Zika Ab QCSiemens Healthcare Diagnostics Inc.QCH2020-02-24
08056771602648LIAISON® XL Zika Capture IgM II Control SetDiasorin Inc.QCH2019-12-04
00630414587448ADVIA Centaur CMV IgG QCSiemens Healthcare Diagnostics Inc.QCH2019-02-10
00630414246482Atellica IM CMV IgG Quality ControlSiemens Healthcare Diagnostics Inc.QCH2018-11-30