Preview

GUDID 10816862021506

Preview hCG Pregnancy Test Cassette

WONDFO USA CO., LTD.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10816862021506
• NIH Device Record Key: 022d5476-7246-404f-90a6-3dc41243b1b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Preview
• Version Model Number: PRE-HCG-25C
• Company DUNS: 849098897
• Company Name: WONDFO USA CO., LTD.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com
• Phone: 8443372743
• Email: info@previewdiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816862021509 [Primary]
GS1	00816862028508 [Unit of Use]
GS1	10816862021506 [Package]; Contains: 00816862021509; Package: [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043443

FDA Product Code

• JHI: Visual, Pregnancy Hcg, Prescription Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-28
• Device Publish Date: 2018-08-28

On-Brand Devices [Preview]

• 10816862021575: Full test for out patient: 25 Cassettes + 25 Collection Tubes + 25 Mailers
• 10816862021568: Test for in-house patient: 25 Cassettes + 25 Collection Tubes
• 10816862021506: Preview hCG Pregnancy Test Cassette
• 10816862021490: Preview hCG Pregnancy Test Strip
• 10816862021483: 12-Panel Preview Dip Card; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
• 10816862021476: 10-Panel Preview Dip Card; AMP,BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,THC
• 10816862021469: 7-Panel Preview Dip Card; AMP, BZO, COC, mAMP, OPI, OXY, THC
• 10816862021452: 5-Panel Preview Dip Card; AMP, COC, mAMP, OPI, THC
• 10816862021438: 7-Panel Preview Cup; AMP,BZO,COC,mAMP,OPI,OXY,THC
• 10816862021421: 5-Panel Preview Cup; AMP,COC,mAMP,OPI,THC
• 00816862021370: 10-Panel Preview Cup; AMP,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,THC
• 10816862021193: 10-Panel Preview Cup; AMP,BUP,BZO,COC,MDMA,MET,MTD,OPI,OXY,THC
• 10816862021186: 12-Panel Preview Cup; AMP,BAR,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,TCA,THC
• 10816862021179: 12-Panel Preview Cup; AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
• 10816862021148: iFOB Fecal Occult Blood Test Kit; 2 Cassettes + 2 Collection Tubes
• 10816862021131: iFOB Fecal Occult Blood Test Kit; 30 Cassettes + 36 Collection Tubes
• 10816862021124: iFOB Fecal Occult Blood Test Kit; 30 Cassettes + 50 Collection Tubes + 50 Mailers
• 10816862020981: 12-Panel Preview Cup 3AD; AMP,BAR,BUP,BZO,COC,MDMA,MET,MTD,OPI,OXY,PCP,THC+CR,SG,pH
• 10816862020967: 2+10 Mini-Midstream Combo; 2 hCG Pregnancy Test + 10 LH Ovulation Test
• 10816862021865: 14-Panel Preview Cup 3AD; AMP, BAR, BUP, BZO, COC, EDDP, mAMP, MDMA, MTD, OPI, OXY, PCP, TCA, TH
• 10816862021803: 5 Panel Preview Cup: AMP1000, COC300, MET1000, MOP300, OXY100
• 10816862021742: 13-Panel Preview Cup; AMP, BAR, BUP, BZO, COC, mAMP, MDMA, MOP, MTD, OXY, PCP, TCA, THC with 3 A
• 10816862021728: Preview Early Result Test Strip
• 00816862021707: 12 Panel Preview Panel,AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC
• 00816862021639: Preview HCG Urine/Serum Combo Pregnancy Test
• 00816862022506: 3-Panel Preview Dip Card; COC,mAMP,THC
• 10816862022466: 20+50 Strip Combo; 20 hCG Pregnancy Test + 50 LH Ovulation Test
• 10816862022459: 50-Strip; LH Ovulation Test
• 00816862022438: AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC
• 00816862022230: 12-Panel Preview Dip Card; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,THC
• 00816862021943: 10-Panel Preview Dip Card; AMP,BAR,BZO,COC,mAMP,MTD,OPI,PCP,TCA,THC
• 10816862021889: 6-Panel Preview Cup; AMP, BUP, COC, mAMP, MTD, OPI
• 10816862021841: 14-Panel Preview Cup; AMP, BAR, BUP, BZO, COC, EDDP, mAMP, MDMA, MTD, OPI, OXY, PCP, TCA, THC
• 10816862021827: THC Single Test
• 10816862021780: 13 Panel Preview Cup: AMP-500, BAR, BUP, BZO, COC-150, MDMA, MAMP/MET-500, MTD, MOP, OXY, PCP, P
• 10816862023586: 25-Strip; Strep A Throat Swab Test
• 10816862022176: 1-Midstreams; hCG Pregnancy Midstream Test Retail Box 1 Pcs Preview 10 MIU
• 10816862023784: 25-Strips;Preview hCG Early Result Pregnancy Test Strip 10 mIU/mL CLIA Waived
• 10816862023722: 10-Strip; Strep A Throat Swab Test