FDA.reportPublic FDA data

Quidel Molecular

Primary DI
30014613311157
Brand
Quidel Molecular
Company
DIAGNOSTIC HYBRIDS, INC.
Model
M115
Catalog number
M115
Device description
QMol Parainflu Control Set
Published
2018-11-16
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHQMulti-analyte controls unassayed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613311157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461331115730014613311157

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory virus 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 nucleic acid from one or multiple viruses associated with respiratory disease in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)552-1100technicalsupport@quidel.com

Regulatory Flags#

DUNS number
117359612
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00050428101735CVS Health At Home COVID-19 Test Kit204522895862025-08-08
30014613340188CVS Health At Home COVID-19 Test Kit204522895862024-11-20
30014613340089Savanna20382R20382R2024-07-19
30014613339304Savanna20382203822024-04-30
30014613340119Savanna20445204452024-04-30
30014613340485SavannaM409-1M409-12024-04-30
30014613340492SavannaM409-4M409-42024-04-30
30014613330486D301-01501001-0150102023-07-10
30014613339090LyraCoronavirusM1202021-02-17
30014613339144LyraCoronavirusM1242021-02-17
30014613339656Solana SARS-CoV-2 AssayCoronavirusM3132021-02-17
30014613339571Fresh Cells72-9624C72-9624C2020-10-02
30014613339564Fresh Cells84-010184-01012020-09-25
30014613339236DHI Specimen Collection System6016012020-07-16
30014613339311DHI Specimen Collection System6026022020-07-16
30014613339274Fresh Cells91-969691-96962020-07-14
30014613339281Fresh Cells50-91-9696-9050-91-9696-902020-07-14
30014613336167SolanaM308M3082020-02-04
30014613312147AmpliVueM214M2142020-01-28
30014613312154AmpliVueM215M2152020-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
70845357044432QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2026-02-10
00852720008244Birlinn™ CoV2-Flu-RSV Control Panel M509MmqciOHQ2025-12-04
01220000260634NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-12-01
70845357044340QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
70845357044395QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
05056850400038Mimix™ Quantitative Multiplex FFPE reference standardREVVITY DISCOVERY LIMITEDOHQ2025-08-15
80845357044422Helix Elite Molecular StandardsMICROBIOLOGICS INC.OHQ2025-08-14
01220000260627NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-08-06
04987270235584Lumipulse Infectious Disease ControlsFUJIREBIO INC.OHQ2025-07-31
01220000260481NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-25
08718734962991CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963004CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963011CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963028CueSee® BGEMEurotrol B.V.OHQ2025-07-25
01220000260498NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-23
00850051429578Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
00850051429639Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
00850051429684Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
05056850400007Mimix™ OncoSpan FFPE Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
05056850400014Mimix™ OncoSpan gDNA Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
05056850400021Mimix™ Myeloid Cancer Panel gDNA Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
01220000260542NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-03-06
08718734962526CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962618CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962625CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962632CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
10845357044324Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.OHQ2024-09-04
70845357044364QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2024-09-04
03610522384372Exact DiagnosticsEXACT DIAGNOSTICS, LLCOHQ2024-08-27
03610522384389Exact DiagnosticsEXACT DIAGNOSTICS, LLCOHQ2024-08-27