FDA.reportPublic FDA data

MHV DNA Amplification Control

Primary DI
00840487101100
Brand
MHV DNA Amplification Control
Company
LUMINEX CORPORATION
Model
3694
Catalog number
3694
Device description
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
Published
2016-12-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLDInternal polymerase chain reaction control, not assay specific

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLDInternal Polymerase Chain Reaction Control, Not Assay SpecificClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487101100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487101100008404871011008404871011000840487101100

GMDN Terms#

Term, Definition table
TermDefinition
Endogenous DNA internal control reagent IVDA substance or reactant intended to be used as an endogenous component in a molecular assay to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA), and/or verify the absence of inhibiting substances, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)327-3290support@luminexcorp.com

Regulatory Flags#

DUNS number
079686463
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840487101438LIAISON PLEX Gastrointestinal Flex Assay20-005-31120-005-3112026-06-08
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
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

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