FDA.reportPublic FDA data

Savanna

Primary DI
30014613340119
Brand
Savanna
Company
DIAGNOSTIC HYBRIDS, INC.
Model
20445
Catalog number
20445
Device description
Savanna HSV 1+2/VZV Assay
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
PGIHerpes virus (VZV, HSV1, HSV2), DNA detection assay for cutaneous and mucocutaneous lesion samples

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion SamplesMicrobiology2

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
30014613340119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461334011930014613340119

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials 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
30014613340485SavannaM409-1M409-12024-04-30
30014613340492SavannaM409-4M409-42024-04-30
30014613330486D301-01501001-0150102023-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999052062Alinity mABBOTT MOLECULAR INC.PGI2025-11-20
00884999050594Alinity mABBOTT MOLECULAR INC.PGI2024-07-27
00884999050570Alinity mABBOTT MOLECULAR INC.PGI2024-07-26
00884999050587Alinity mABBOTT MOLECULAR INC.PGI2024-07-26
20816101025712Simplexa™ VZV Swab DirectDIASORIN MOLECULAR LLCPGI2019-12-13
00840733102158Alethia™ HSV 1&2 External Control KitMERIDIAN BIOSCIENCE, INC.PGI2019-01-09
00840733102219Alethia™ HSV 1&2MERIDIAN BIOSCIENCE, INC.PGI2019-01-09
03661540950025HSV 1&2 ELITe MGB AssayElitechgroup Mdx LLCPGI2018-12-14
30014613336105SolanaDIAGNOSTIC HYBRIDS, INC.PGI2018-08-07
00840733101151illumigene HSV 1&2 External Control KitMERIDIAN BIOSCIENCE, INC.PGI2016-09-23
00840733101182illumigene HSV 1&2MERIDIAN BIOSCIENCE, INC.PGI2016-09-23
30014613311027LyraQUIDEL CORPORATIONPGI2016-09-15
00840487100295ARIES® HSV 1&2 AssayLUMINEX CORPORATIONPGI2016-09-09