CRL Stat Dip Card KCUR920082

GUDID 00817815020686

DOA 11 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box AMP1000 BAR300 BZO300 COC300 MET1000 MTD300 OPI2000 OXY100 PCP25 PPX300 THC50 & pH SG OX CR NI

W.H.P.M. INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID00817815020686
NIH Device Record Key78ba4bf0-53f3-494d-9f7f-63f10ebc08e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRL Stat Dip Card
Version Model NumberKCUR920082
Catalog NumberKCUR920082
Company DUNS602085672
Company NameW.H.P.M. INC.
Device Count25
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100817815020686 [Unit of Use]
GS110817815020683 [Primary]

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-02
Device Publish Date2021-08-25

On-Brand Devices [CRL Stat Dip Card]

00817815020471DOA 8 in 1 Test CRL Stat Dip Card W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 MET1000 BAR300 BZO300
00817815020686DOA 11 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box AMP1000 BAR300 BZO300 COC300 MET1000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.