FDA.reportPublic FDA data

Elecsys Anti-HBc II

Primary DI
07613336228487
Brand
Elecsys Anti-HBc II
Company
Roche Diagnostics GmbH
Model
09014926162
Catalog number
09014926162
Published
2025-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QHMSerology tests used for infectious disease screening of blood and plasma donations

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QHMSerology Tests Used For Infectious Disease Screening Of Blood And Plasma DonationsMicrobiologyU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336183106PrimaryGS10
07613336228487Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336183106076133361831067613336183106
07613336228487076133362284877613336228487

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus core antigen IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus core antigen in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
07613336200544cobas c 703 analytical unit09502971001095029710012026-03-20
07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336183106Elecsys Anti-HBc IIRoche Diagnostics GmbHQHM2025-02-19
07613336183120Elecsys HIV DuoRoche Diagnostics GmbHQHM2025-02-19
07613336183045PreciControl Release HIV Gen IIRoche Diagnostics GmbHQHM2025-02-19
07613336228500Elecsys HIV DuoRoche Diagnostics GmbHQHM2025-02-19
07613336183212PreciControl HIV Gen IIRoche Diagnostics GmbHQHM2025-02-19
07613336183229PreciControl HIV; HIV-2+GrpORoche Diagnostics GmbHQHM2025-02-19
07613336183052Elecsys Anti-HCV IIRoche Diagnostics GmbHQHM2025-02-18
07613336183090Elecsys HTLV-I/IIRoche Diagnostics GmbHQHM2025-02-18
07613336183113Elecsys ChagasRoche Diagnostics GmbHQHM2025-02-18
07613336182970PreciControl Release Anti-HCVRoche Diagnostics GmbHQHM2025-02-18
07613336183014PreciControl Release HTLVRoche Diagnostics GmbHQHM2025-02-18
07613336183021PreciControl Release Anti-HBc IIRoche Diagnostics GmbHQHM2025-02-18
07613336183038PreciControl Release ChagasRoche Diagnostics GmbHQHM2025-02-18
07613336228432Elecsys Anti-HCV IIRoche Diagnostics GmbHQHM2025-02-18
07613336228470Elecsys HTLV-I/IIRoche Diagnostics GmbHQHM2025-02-18
07613336228494Elecsys ChagasRoche Diagnostics GmbHQHM2025-02-18
07613336183144PreciControl Anti-HCVRoche Diagnostics GmbHQHM2025-02-18
07613336183182PreciControl HTLVRoche Diagnostics GmbHQHM2025-02-18
07613336183199PreciControl Anti-HBc IIRoche Diagnostics GmbHQHM2025-02-18
07613336183205PreciControl ChagasRoche Diagnostics GmbHQHM2025-02-18
07613336183076Elecsys HBsAg IIRoche Diagnostics GmbHQHM2024-11-07
07613336182994PreciControl Release HBsAg IIRoche Diagnostics GmbHQHM2024-11-07
07613336228456Elecsys HBsAg IIRoche Diagnostics GmbHQHM2024-11-07
07613336183137Elecsys HBsAg II Auto ConfirmRoche Diagnostics GmbHQHM2024-11-07
07613336183168PreciControl HBsAg IIRoche Diagnostics GmbHQHM2024-11-07
03610521168942GeeniusBio-RAD Laboratories, Inc.QHM2023-07-28
03610522162239GeeniusBio-RAD Laboratories, Inc.QHM2023-07-28
03610522162260GeeniusBio-RAD Laboratories, Inc.QHM2023-07-28
03610522168064GeeniusBio-RAD Laboratories, Inc.QHM2023-07-28