FDA.reportPublic FDA data

QUANTA Lite® M2 EP (MIT3) ELISA Bulk Pack

Primary DI
08426950596301
Brand
QUANTA Lite® M2 EP (MIT3) ELISA Bulk Pack
Company
INOVA DIAGNOSTICS, INC.
Model
704540.10
Device description
1. 10x M2 EP (MIT3) ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted M2 EP (MIT3) ELISA Low Positive4. 5x 1.2mL prediluted M2 EP (MIT3) ELISA High Positive5. 9x 50mL HRP Sample Diluent6. 10x 25mL HRP Wash Concentrate, 40x concentrate7. 10x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 10x 10mL TMB Chromogen9. 10 x10mL HRP Stop Solution, 0.344M Sulfuric Acid
Published
2016-08-31
Public version status
Update
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
DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052262000QUANTA LITE M2 EP (MIT3) ELISAInova Diagnostics, Inc.2005-10-27DBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950596301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950596301084269505963018426950596301

GMDN Terms#

Term, Definition table
TermDefinition
Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antibodies to mitochondria M2 (anti-Mi2) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
1-800-545-9495support@inovadx.com

Regulatory Flags#

DUNS number
188354831
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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08426950621843NOVA Lite® DAPI ANA Kit7043202016-08-31
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