FDA.reportPublic FDA data

Savanna

Primary DI
30014613340492
Brand
Savanna
Company
DIAGNOSTIC HYBRIDS, INC.
Model
M409-4
Catalog number
M409-4
Device description
Savanna HSV 1+2/VZV Control Set
Published
2024-04-30
Public version status
New
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
PMNAssayed external control material for microbiology nucleic acid amplification (NAT) assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) AssaysMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232286000Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentQuidel Corporation2023-12-20PGI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613340492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461334049230014613340492

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type sexually transmitted pathogen 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 multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117359612
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30014613330288D3 Ultra01-010000.V201-010000.V22019-03-07
30014613330875D3 Fastpoint01-12350401-1235042019-03-07
00050428101735CVS Health At Home COVID-19 Test Kit204522895862025-08-08
30014613340089Savanna20382R20382R2024-07-19
30014613339304Savanna20382203822024-04-30
30014613340188CVS Health At Home COVID-19 Test Kit204522895862024-11-20
30014613330240D301-0005001-000502019-04-02
30014613311034LyraM103M1032016-09-15
30014613311157Quidel MolecularM115M1152018-11-16
30014613330752D3 FastpointRespiratory Virus ID Kit01-1200002016-09-15
30014613330769D3 Fastpoint01-120000.B101-120000.B12018-07-22
30014613330776D3 Fastpoint01-120000.B201-120000.B22018-07-22
30014613330813D3 FastpointRSV/MPV ID Kit01-1200022016-09-15
30014613330820D3 Fastpoint01-120002.B101-120002.B12018-07-22
30014613330837D3 Fastpoint01-120002.B201-120002.B22018-07-22
30014613336143SolanaM306M3062018-08-07
30014613338659D301-002007b01-002007b2019-04-23
30014613340119Savanna20445204452024-04-30
30014613340485SavannaM409-1M409-12024-04-30
30014613330486D301-01501001-0150102023-07-10

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Primary DI, Brand, Company table
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00850063063012DASH® Negative Control Swabs KitNuclein, LLCPMN2025-01-06
00850063063029DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs KitNuclein, LLCPMN2025-01-06
15420045517059Aptima®Hologic, Inc.PMN2024-12-19
15420045517066Aptima®Hologic, Inc.PMN2024-12-19
30014613340485SavannaDIAGNOSTIC HYBRIDS, INC.PMN2024-04-30
00852720008091SPOTFIRE RSP Positive ControlMmqciPMN2023-09-15
00852720008107SPOTFIRE RSP Negative ControlMmqciPMN2023-09-15
00851458005273BioFire® Global Fever Special Pathogens PanelBIOFIRE DEFENSE, LLCPMN2023-08-31
00851458005280BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens PaneBIOFIRE DEFENSE, LLCPMN2023-08-31
00844509002437MDx-Chex for BC-GNSTRECK, INC.PMN2023-08-09
00844509002468MDx-Chex for BC-GPSTRECK, INC.PMN2023-08-09
00852720008121BioFire JI Control Panel M420MmqciPMN2022-11-14
01220000260238NATtrol™ZEPTOMETRIX CORPORATIONPMN2022-03-31
01220000260245NATtrol™ZEPTOMETRIX CORPORATIONPMN2022-03-31
01220000260252NATtrol™ZEPTOMETRIX CORPORATIONPMN2022-03-31
00844509002338MDx-Chex for BCID2STRECK, INC.PMN2022-01-25
00852720008114BioFire RP2.1/RP2.1plus Control Panel M441MmqciPMN2021-09-16
00851458005259BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel BIOFIRE DEFENSE, LLCPMN2021-07-16
00852720008077FilmArray BCID2 Control Panel M416MmqciPMN2021-02-18
00852720008053FilmArray Warrior Control Panel M290MmqciPMN2020-11-24
00852720008046FilmArray RP EZ Control Panel M265MmqciPMN2020-01-22
00852720008039FilmArray RP2/RP2plus Control PanelMmqciPMN2019-12-31
70845357041240QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.PMN2019-10-31
70845357041226QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.PMN2019-08-31
70845357041233QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.PMN2019-08-31
15420045512023Aptima®Hologic, Inc.PMN2019-07-02
15420045512030Aptima®Hologic, Inc.PMN2019-07-02