FDA.reportPublic FDA data

ARIES® HSV 1&2 Assay

Primary DI
00840487100295
Brand
ARIES® HSV 1&2 Assay
Company
LUMINEX CORPORATION
Model
50-10017
Device description
The ARIES® HSV 1 & 2 Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus (HSV) DNA from cutaneous and mucocutaneous lesion swab specimens.
Published
2016-09-09
Public version status
Update
Distribution status
Not 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
K151906000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151906000ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)Luminex Corporation2015-10-06PGI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487100295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487100295008404871002958404871002950840487100295

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 & 2 (HSV1 & 2) 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 herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(512)381-4397support@luminexcorp.com

Regulatory Flags#

DUNS number
965476641
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge20-006-00120-006-0012019-12-05
00840487101728Hypercoagulation Panel (HC) Sample Buffer30-001-00130-001-0012019-12-05
00840487101858LIAISON PLEX Gram-Positive Blood Culture Assay20-005-30520-005-3052025-07-11
00840487101865LIAISON PLEX Yeast Blood Culture Assay Kit20-005-30620-005-3062024-10-22
00840487101940LIAISON PLEX® Respiratory Flex Assay Kit20-005-32220-005-3222024-06-20
00840487101841LIAISON PLEX Gram-Negative Blood Culture Assay20-005-30320-005-3032025-06-11
00840487100127MHV Control Primers 5380638062016-12-16
00840487100233MultiCode® Chlamydophila pneumoniae Primers392539252016-12-16
00840487100240MultiCode® Legionella pneumophila Primers392639262016-12-16
00840487100257MultiCode® Mycoplasma pneumoniae Primers392739272016-12-16
00840487101049MHV DNA Sample Processing Control370037002016-12-16
00840487101056MHV DNA Sample Processing Control3700-023700-022016-12-16
00840487101063MHV DNA Sample Processing Control3700-213700-212016-12-16
00840487101070MHV DNA Sample Processing Control3700-223700-222016-12-16
00840487101087MHV DNA Sample Processing Control371037102016-12-16
00840487101100MHV DNA Amplification Control369436942016-12-16
00840487101155MHV Control Primers 1380238022016-12-16
00840487101179MHV Control Primers 2380338032016-12-16
00840487101186MHV Control Primers 23803-213803-212016-12-16
00840487101193MHV Control Primers 3380438042016-12-16

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
30014613340119SavannaDIAGNOSTIC HYBRIDS, INC.PGI2024-04-30
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