FDA.reportPublic FDA data

NOVA Lite® Monkey Oesophagus IFA Kit

Primary DI
08426950513988
Brand
NOVA Lite® Monkey Oesophagus IFA Kit
Company
INOVA DIAGNOSTICS, INC.
Model
704145
Device description
1. 10 x Monkey Oesophagus – 5-well slide2. 1 x 1mL Pemphigus Positive Control (prediluted)3. 1 x 1mL Endomysial (Celiac) Positive Control (prediluted)4. 1 x 1mL IFA System Negative Control (prediluted)5. 1 x 7mL FITC IgG (H&L), monkey adsorbed Conjugate6. 1 x 7mL Anti-Human IgA (α) AFF FITC7. 1 x 3mL 1% Evans Blue Counterstain8. 2 x 25mL PBS II concentrate (x40)9. 1 x 3mL Mounting Medium10. 10 x Coverslips 11. 1 x instruction leaflet
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
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981209000MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITSThe Binding Site, Ltd.1998-10-22MVM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950513988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950513988084269505139888426950513988

GMDN Terms#

Term, Definition table
TermDefinition
Skin antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to skin in a clinical specimen, using a fluorescent immunoassay method. This test is typically used to aid the diagnosis of skin disorders (e.g., autoimmune bullous dermatoses such as pemphigus vulgaris, paraneoplastic pemphigus, or dermatitis herpetiformis); antibodies detected are typically directed at structural proteins of the skin and/or superficial mucosa (e.g., gliadin, desmoglein, collagen, endomysium).

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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