FDA.reportPublic FDA data

illumigene HSV 1&2 External Control Kit

Primary DI
00840733101151
Brand
illumigene HSV 1&2 External Control Kit
Company
MERIDIAN BIOSCIENCE, INC.
Model
279960
Catalog number
279960
Device description
The illumigene HSV 1&2 External Control Kit contains Positive and Negative Control Reagents for use with the illumigene HSV 1&2 DNA Amplification Assay. External controls are used as part of a routine quality control program.
Published
2016-09-23
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
K151046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151046000illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10Meridian Bioscience, Inc.2015-07-17PGI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101151008407331011518407331011510840733101151

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
513-271-3700info@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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00840733102318Revogene6102106102102020-07-15
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00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
00840733102714Para-Pak C&S9006129006122020-12-09
00840733102455Para-Pak Ultra SAF9802129802122020-12-09
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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
00840733101182illumigene HSV 1&2MERIDIAN BIOSCIENCE, INC.PGI2016-09-23
30014613311027LyraQUIDEL CORPORATIONPGI2016-09-15
00840487100295ARIES® HSV 1&2 AssayLUMINEX CORPORATIONPGI2016-09-09