FDA.report

STATDIP®

Primary DI
00816036020123
Brand
STATDIP®
Company
MICRO DISTRIBUTING, L.C
Model
DMT-114
Catalog number
DMT-114
Device description
STAT DOA Single Test CLIA Waived Dipcard, 25Pcs/Box MTD
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
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
00816036020123PrimaryGS10
00816036020512Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816036020123008160360201238160360201230816036020123
00816036020512008160360205128160360205120816036020512

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.

Sterilization Methods

Method

Contacts

PhoneEmail
866-933-0964info@micro-distributing.com

Regulatory Flags

DUNS number
087732173
Device count
25
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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