FDA.report

DrugCheck

Primary DI
B298301600
Brand
DrugCheck
Company
EXPRESS DIAGNOSTICS INT'L, INC.
Model
30160
Catalog number
30160
Device description
Single Dip Drug Test, OPI
Published
2016-08-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DJGEnzyme Immunoassay, Opiates

Product Code Classifications

CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B298301600PrimaryHIBCC0

GMDN Terms

TermDefinition
Opiate/opiate metabolite IVD, kit, immunochromatographic test (ICT)A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of opiate and/or opiate metabolites in a clinical specimen, using an immunochromatographic test (ICT) method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
506-526-3951quality@drugcheck.com

Regulatory Flags

DUNS number
168560402
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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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B298304500DrugCheck30450304502016-09-12

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