CRL Stat Dip Card KCUR920121P

GUDID 00817815020471

DOA 8 in 1 Test CRL Stat Dip Card W/ AD, CLIA Waived, 25Pcs/Box, AMP1000 MET1000 BAR300 BZO300 COC300 THC50 PCP25 OPI2000 & CR, NI, OX, PH, SG

W.H.P.M. INC.

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Primary Device ID00817815020471
NIH Device Record Key740cbacb-34cd-4233-9ba9-8d912e3f8d65
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRL Stat Dip Card
Version Model NumberKCUR920121
Catalog NumberKCUR920121P
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
GS100817815020464 [Unit of Use]
GS100817815020471 [Primary]

FDA Product Code

LCMEnzyme Immunoassay, Phencyclidine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-22
Device Publish Date2019-10-14

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

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