Preview

GUDID 10816862023784

25-Strips;Preview hCG Early Result Pregnancy Test Strip 10 mIU/mL CLIA Waived

WONDFO USA CO., LTD.

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Primary Device ID10816862023784
NIH Device Record Keyef4c6175-0437-4561-aee7-8ba48ca754ec
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreview
Version Model NumberPRE-HCG-25SE-CLIA
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 Perscriptionfalse
OTC Over-The-Counterfalse

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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816862023787 [Primary]
GS100816862023794 [Unit of Use]
GS110816862023784 [Package]
Contains: 00816862023787
Package: [120 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JHIVisual, Pregnancy Hcg, Prescription Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-11
Device Publish Date2023-08-03

On-Brand Devices [Preview]

10816862021575Full test for out patient: 25 Cassettes + 25 Collection Tubes + 25 Mailers
10816862021568Test for in-house patient: 25 Cassettes + 25 Collection Tubes
10816862021506Preview hCG Pregnancy Test Cassette
10816862021490Preview hCG Pregnancy Test Strip
1081686202148312-Panel Preview Dip Card; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
1081686202147610-Panel Preview Dip Card; AMP,BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,THC
108168620214697-Panel Preview Dip Card; AMP, BZO, COC, mAMP, OPI, OXY, THC
108168620214525-Panel Preview Dip Card; AMP, COC, mAMP, OPI, THC
108168620214387-Panel Preview Cup; AMP,BZO,COC,mAMP,OPI,OXY,THC
108168620214215-Panel Preview Cup; AMP,COC,mAMP,OPI,THC
0081686202137010-Panel Preview Cup; AMP,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,THC
1081686202119310-Panel Preview Cup; AMP,BUP,BZO,COC,MDMA,MET,MTD,OPI,OXY,THC
1081686202118612-Panel Preview Cup; AMP,BAR,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,TCA,THC
1081686202117912-Panel Preview Cup; AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
10816862021148iFOB Fecal Occult Blood Test Kit; 2 Cassettes + 2 Collection Tubes
10816862021131iFOB Fecal Occult Blood Test Kit; 30 Cassettes + 36 Collection Tubes
10816862021124iFOB Fecal Occult Blood Test Kit; 30 Cassettes + 50 Collection Tubes + 50 Mailers
1081686202098112-Panel Preview Cup 3AD; AMP,BAR,BUP,BZO,COC,MDMA,MET,MTD,OPI,OXY,PCP,THC+CR,SG,pH
108168620209672+10 Mini-Midstream Combo; 2 hCG Pregnancy Test + 10 LH Ovulation Test
1081686202186514-Panel Preview Cup 3AD; AMP, BAR, BUP, BZO, COC, EDDP, mAMP, MDMA, MTD, OPI, OXY, PCP, TCA, TH
108168620218035 Panel Preview Cup: AMP1000, COC300, MET1000, MOP300, OXY100
1081686202174213-Panel Preview Cup; AMP, BAR, BUP, BZO, COC, mAMP, MDMA, MOP, MTD, OXY, PCP, TCA, THC with 3 A
10816862021728Preview Early Result Test Strip
0081686202170712 Panel Preview Panel,AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC
00816862021639Preview HCG Urine/Serum Combo Pregnancy Test
008168620225063-Panel Preview Dip Card; COC,mAMP,THC
1081686202246620+50 Strip Combo; 20 hCG Pregnancy Test + 50 LH Ovulation Test
1081686202245950-Strip; LH Ovulation Test
00816862022438AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC
0081686202223012-Panel Preview Dip Card; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,THC
0081686202194310-Panel Preview Dip Card; AMP,BAR,BZO,COC,mAMP,MTD,OPI,PCP,TCA,THC
108168620218896-Panel Preview Cup; AMP, BUP, COC, mAMP, MTD, OPI
1081686202184114-Panel Preview Cup; AMP, BAR, BUP, BZO, COC, EDDP, mAMP, MDMA, MTD, OPI, OXY, PCP, TCA, THC
10816862021827THC Single Test
1081686202178013 Panel Preview Cup: AMP-500, BAR, BUP, BZO, COC-150, MDMA, MAMP/MET-500, MTD, MOP, OXY, PCP, P
1081686202358625-Strip; Strep A Throat Swab Test
108168620221761-Midstreams; hCG Pregnancy Midstream Test Retail Box 1 Pcs Preview 10 MIU
1081686202378425-Strips;Preview hCG Early Result Pregnancy Test Strip 10 mIU/mL CLIA Waived
1081686202372210-Strip; Strep A Throat Swab Test

Trademark Results [Preview]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PREVIEW
PREVIEW
97926447 not registered Live/Pending
Efuetlateh, Michael A
2023-05-08
PREVIEW
PREVIEW
97643213 not registered Live/Pending
Astute Imaging LLC
2022-10-21
PREVIEW
PREVIEW
97245982 not registered Live/Pending
UPL Corporation Ltd.
2022-01-31
PREVIEW
PREVIEW
97187383 not registered Live/Pending
Efuetlateh, Michael A
2021-12-23
PREVIEW
PREVIEW
97071895 not registered Live/Pending
Association of American Medical Colleges
2021-10-13
PREVIEW
PREVIEW
88260885 not registered Live/Pending
Brother International Corporation
2019-01-14
PREVIEW
PREVIEW
87790803 not registered Live/Pending
Perimetrics, LLC
2018-02-08
PREVIEW
PREVIEW
87558103 not registered Live/Pending
United Phosphorus, Inc.
2017-08-07
PREVIEW
PREVIEW
87454951 5515084 Live/Registered
I&EYE Enterprises, LLC
2017-05-18
PREVIEW
PREVIEW
87130136 5137662 Live/Registered
Tapestry Networks, Inc.
2016-08-08
PREVIEW
PREVIEW
86292278 5147023 Live/Registered
DSA International, LLC
2014-05-27
PREVIEW
PREVIEW
86032232 4650044 Live/Registered
Mastic Home Exteriors, Inc.
2013-08-08
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.