FDA.report

Healgen

Primary DI
20816490020596
Brand
Healgen
Company
Healgen Scientific Limited Liability Company
Model
HDOA-5064
Catalog number
HDOA-5064
Device description
6 Panel DOA Test Dipcard
Published
2017-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DJREnzyme Immunoassay, Methadone

Product Code Classifications

CodeDeviceSpecialtyClass
DJREnzyme Immunoassay, MethadoneClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10816490020599PackageGS125In Commercial Distribution
20816490020596PackageGS120In Commercial Distribution
00816490020592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081649002059910816490020599
2081649002059620816490020596
00816490020592008164900205928164900205920816490020592

GMDN Terms

TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
7137338088bryan@healgen.com

Regulatory Flags

DUNS number
031802328
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10810173655948HealgenHCDOAV-5125SF72026-03-11
10810173655955HealgenHCDOAV-5642026-03-11
10810173655962HealgenHCDOAV-6125A3A2026-03-11
10810173655979HealgenHCDOAV-8552026-03-11
10810173655986HealgenHDMO-1142026-03-11
10810173655993HealgenHDOA-11442026-03-11
10810173656006HealgenHDOA-1242026-03-11
10810173656013HealgenHDOA-2342026-03-11
10810173656020HealgenHDOA-31242026-03-11
10810173656037HealgenHDOX-1142026-03-11
10810173655047HealgenHDOA-2542026-02-04
00810173655507Healgen HCDOAV-51252026-02-04
10810173655566HealgenHCDOAF-6125A3C2026-02-04
10810173655580HealgenHCDOAV-1642026-02-04
10810173655597HealgenHCDOAV-2542026-02-04
10810173655658HealgenHCDOAV-81042026-02-04
10810173655689HealgenHDOA-2642026-02-04
00810173654920HealgenHDOA-11242026-01-31

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