FDA.report

INSTANT-VIEW Methamphetamine (500) Urine Dip-Strip Test

Primary DI
10796918000375
Brand
INSTANT-VIEW Methamphetamine (500) Urine Dip-Strip Test
Company
ALFA SCIENTIFIC DESIGNS, INC.
Model
03-3038
Device description
INSTANT-VIEW Methamphetamine (500) Urine Dip-Strip Test
Published
2016-09-21
Public version status
Update
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
DJCThin Layer Chromatography, Methamphetamine

Product Code Classifications

CodeDeviceSpecialtyClass
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10796918000375PrimaryGS10
00796918000378Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1079691800037510796918000375
00796918000378007969180003787969180003780796918000378

GMDN Terms

TermDefinition
Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of a specific methamphetamine 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
176391167
Device count
50
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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