Genova Diagnostics

Primary DI
00860010591109
Brand
Genova Diagnostics
Company
Genova Diagnostics, Inc.
Model
Intestinal Permeability Drink Concentrate
Device description
The Intestinal Permeability Drink Concentrate is intended to facilitate the measurement of lactulose to mannitol in urine; the measurement is used in the diagnosis of gastrointestinal malabsorption syndroms
Published
2023-08-08
Public version status
New
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
JOCColorimetric, Xylose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOCColorimetric, XyloseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010591109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010591109008600105911098600105911090860010591109

GMDN Terms#

Term, Definition table
TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-522-4762xxx@xx.xx

Regulatory Flags#

DUNS number
603179581
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true