FDA.report

STATDIP®

Primary DI
00816036020161
Brand
STATDIP®
Company
MICRO DISTRIBUTING, L.C
Model
SDP-234
Catalog number
SDP-234
Device description
STAT 3 in 1 CLIA Waived Test Dipcard, 25Pcs/Box COC/mAMP/THC
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
DKEReagents, Test, Tetrahydrocannabinol

Product Code Classifications

CodeDeviceSpecialtyClass
DKEReagents, Test, TetrahydrocannabinolClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816036020161PrimaryGS10
00816036020543Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816036020161008160360201618160360201610816036020161
00816036020543008160360205438160360205430816036020543

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.

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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00816036028013STATSWAB3SS3-158SS3-1582021-09-16
00816036028020STATSWAB3SS3-168SS3-1682021-09-16
00816036021922STATDIP®SDP-044SDP-0442021-08-09
00816036021908STATCUP® IISTAII-1247STAII-12472021-08-04
00816036025463STATCUP® IISTAII-03107-0-ASTAII-03107-0-A2021-08-03
00816036026439STATDIP®DTH-40-0DTH-40-02020-06-02

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