FDA.report

DrugCheck

Primary DI
B2986102010
Brand
DrugCheck
Company
Express Diagnostic Int'l, Inc.
Model
61020
Catalog number
61020
Device description
10 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-OXY-PCP-THC
Published
2019-04-12
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

Product Codes

CodeName
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications

CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B2986102010PrimaryHIBCC0

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 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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