FDA.report

DrugCheck

Primary DI
B29830100C10
Brand
DrugCheck
Company
Express Diagnostic Int'l, Inc.
Model
30100C
Catalog number
30100C
Device description
Single Dip Cassette Drug Test, MTD
Published
2019-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
B29830100C10PrimaryHIBCC0

GMDN Terms

TermDefinition
Methadone 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 methadone 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
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
507-526-3951quality@drugcheck.com

Regulatory Flags

DUNS number
015875273
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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