FDA.report

DrugCheck

Primary DI
B298312010
Brand
DrugCheck
Company
EXPRESS DIAGNOSTICS INT'L, INC.
Model
31201
Catalog number
31201
Device description
12 Panel Dip Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-PPX-THC
Published
2016-09-12
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

Contact Domains

Product Codes

CodeName
DKZEnzyme Immunoassay, Amphetamine

Product Code Classifications

CodeDeviceSpecialtyClass
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B298312010PrimaryHIBCC0

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
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
507-526-3951quality@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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B298304020DrugCheck30402304022016-09-07
B298304100DrugCheck30410304102016-09-07
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B298304450DrugCheck30445304452016-08-29
B298304500DrugCheck30450304502016-09-12

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B2987050460DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-20
B298307220DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-19
B298605010DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-19
10810173655665HealgenHealgen Scientific Limited Liability CompanyDKZ2026-01-30
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