T-Cup Flat

GUDID 00816862022407

12-Panel T-Cup Flat; AMP, BAR, BUP, BZO, COC, mAMP, MDMA, MOP, MTD, OXY, PCP, THC

WONDFO USA CO., LTD.

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, 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 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 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 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 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 Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID00816862022407
NIH Device Record Key2ac22b77-ccb1-425c-9a15-0b6743232fc7
Commercial Distribution StatusIn Commercial Distribution
Brand NameT-Cup Flat
Version Model NumberFDOA-6125
Company DUNS849098897
Company NameWONDFO USA CO., LTD.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Customer Support Contacts

Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816862022384 [Primary]
GS100816862022391 [Unit of Use]
GS100816862022407 [Package]
Contains: 00816862022384
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2020-05-04
Device Publish Date2020-04-24

Devices Manufactured by WONDFO USA CO., LTD.

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10816862024125 - T-Cup2023-08-17 10-Panel T-Cup; AMP,BAR,BZO,COC,MDMA,MTD,OPI,OXY,PCP,THC
10816862022756 - Wondfo2023-08-11 PREGNANCY MIDSTREAM TEST
10816862023036 - T-Dip2023-08-11 3-Panel Card;COC300,OPI2000,THC50
10816862023722 - Preview2023-08-11 10-Strip; Strep A Throat Swab Test
10816862023760 - Prime Screen2023-08-11 1-Panel Card; 25 per box; One Step THC Urine Test
10816862023784 - Preview2023-08-11 25-Strips;Preview hCG Early Result Pregnancy Test Strip 10 mIU/mL CLIA Waived
10816862023807 - Wondfo2023-08-11 1-Cassette; hCG Pregnancy Test 25 mIU/mL CLIA Waived
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