FDA.reportPublic FDA data

PreciControl HTLV

Primary DI
07613336183182
Brand
PreciControl HTLV
Company
Roche Diagnostics GmbH
Model
07108133162
Catalog number
07108133162
Published
2025-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
07613336183182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336183182076133361831827613336183182

GMDN Terms#

Term, Definition table
TermDefinition
Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, controlA material which is used to verify the performance of an assay that is used for the qualitative and/or quantitative detection of antibodies to human T-cell lymphotrophic virus 1 and 2 (HTLV1 and HTLV2) in a clinical specimen.

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
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
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
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

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
07613336228487Elecsys Anti-HBc 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
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