Healgen

Primary DI
00816490021100
Brand
Healgen
Company
Healgen Scientific Limited Liability Company
Model
HURS-1T
Catalog number
HURS-1T
Device description
1 parameter Urine Strip
Published
2017-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111999000HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINALHealgen Scientific,, LLC2012-04-17JIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816490021107PackageGS1100In Commercial Distribution
20816490021104PackageGS1100In Commercial Distribution
00816490021100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081649002110710816490021107
2081649002110420816490021104
00816490021100008164900211008164900211000816490021100

GMDN Terms#

Term, Definition table
TermDefinition
Urine ketone IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for ketones within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
031802328
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810173656726HealgenHCDOAV-1145SA52026-06-03
00810173656733HealgenHCDOAV-154A32026-06-03
00810173656740HealgenHCDOAV-2145A32026-06-03
00810173656757HealgenHCDOAV-274A32026-06-03
00810173656764HealgenHCDOAV-41042026-06-03
00810173656771HealgenHDOA-1442026-06-03
00810173656788HealgenHDOA-1842026-06-03
00810173656702AccurateHCDOAF-22105SA32026-06-02
00810173656177Healgen HCDOAF-2542026-05-08
00810173656399HealgenHCDOAV-2652026-05-08
00810173656405HealgenHDOA-1104C2026-05-08
00810173656412HealgenHDOA-1942026-05-08
00810173656429HealgenHDOA-2652026-05-08
00810173656139Healgen HCDOAEW-131042026-04-16
00810173656344HealgenHCDOAEW-21352026-04-16
00810173656351HealgenHCDOAEW-41042026-04-16
00810173655118HealgenHCDOAEW-61252026-04-15
00810173655774Healgen HCDOAB-385T3AD2026-04-15
00810173655781HealgenHDOA-51252026-04-15
00810173655798HealgenHDOA-5352026-04-15