Sure-Vue 23900535

GUDID 00613647000519

SURE-VUE H. PYLORI 30/PK

FISHER SCIENTIFIC COMPANY L.L.C.

Helicobacter pylori antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00613647000519
• NIH Device Record Key: 96cf92c6-ab63-4f9b-8bff-a3cf5e2b5805
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure-Vue
• Version Model Number: 4581465021
• Catalog Number: 23900535
• Company DUNS: 004321519
• Company Name: FISHER SCIENTIFIC COMPANY L.L.C.
• Device Count: 30
• 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: true
• 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: false

Customer Support Contacts

• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com
• Phone: +018007667000
• Email: Regulatory.Affairs@thermofisher.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613647000519 [Primary]
GS1	10613647000516 [Unit of Use]

FDA Product Code

• LYR: Helicobacter pylori

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Sure-Vue]

• 00613647001325: SURE-VUE MONO 1000 TESTS
• 00613647001318: SURE-VUE MONO 150 TESTS
• 00613647001301: SURE-VUE MONO 50 TESTS
• 00613647001295: SURE-VUE RF 500 TESTS
• 00613647001288: SURE-VUE CRP 500 TESTS/PK
• 00613647001271: SURE-VUE CRP 50TEST/PK
• 00613647001264: SURE-VUE RF 50TEST/PK
• 00613647001257: SURE-VUE RF 100TEST/PK
• 00613647001240: SELECT RUBELLA 500 TST/PK
• 00613647001233: Sure-Vue SELECT Rubella 100 T
• 00613647001226: SURE-VUE RUBELLA 500TST/PK
• 00613647001219: SURE-VUE RUBELLA 100TST/PK
• 00613647001202: Sure-Vue Color Mono 50 T
• 00613647001196: Sure-Vue Color Mono 24T
• 00613647000588: SURE-VUE HCGDIPSTICK URIN25/PK
• 00613647000571: SURE-VUE HCG STAT SER/UR 30/PK
• 00613647000564: SURE-VUE HCG SERUM/URINE 30/PK
• 00613647000557: SURE-VUE STREP A 27/PK
• 00613647000540: SURE-VUE HCG SERUM/URINE 50/PK
• 00613647000533: SURE-VUE HCG STAT SER/UR 50/PK
• 00613647000526: SURE-VUE HCG URINE 30/PK
• 00613647000519: SURE-VUE H. PYLORI 30/PK
• 20613647000315: Sure-Vue Signature Cryptosporidium and Giardia Control Kit
• 20613647000308: Sure-Vue Signature Cryptosporidium and Giardia Test Kit
• 20613647000292: Sure-Vue Signature Strep A
• 20613647000285: Sure-Vue Signature Mononucleosis
• 00613647001578: Sure-Vue Signature Automated RPR 480 Tests
• 00613647000977: Sure-Vue Signature Automated RPR Titer Diluent 20ml
• 00613647001622: Sure-Vue Signature Automated RPR Titer Diluent 20ml
• 00613647001615: Sure-Vue Signature Automated RPR Control Set 3 x 5mL/PK
• 00613647001608: Sure-Vue Signature Automated RPR Control Set 3 X 2.5mL/PK
• 00613647001592: Sure-Vue Signature Automated RPR 9,600 Test kit
• 00613647001585: Sure-Vue Signature Automated RPR 4,800 Test kit
• 10613647001469: Sure-Vue Signature iFOBT Controls +/-
• 10613647001438: Sure-Vue Signature iFOBT 50 test cassettes only
• 10613647001421: Sure-Vue Signature iFOBT 50 test kit with 50 tubes
• 10613647001414: Sure-Vue Signature iFOBT 30 test kit with 30 tubes
• 10613647001407: Sure-Vue Signature iFOBT 30 test kit with 50 tubes and 50 mailers
• 10613647001445: Sure-Vue Signature iFOBT 50 collection tubes only
• 00006136471288: SURE-VUE CRP 500 TESTS/PK
• 00006136471271: SURE-VUE CRP 50TEST/PK
• 00006136471240: SELECT RUBELLA 500 TST/PK
• 00006136471233: Sure-Vue SELECT Rubella 100 T
• 00006136471226: SURE-VUE RUBELLA 500TST/PK
• 00006136471219: SURE-VUE RUBELLA 100TST/PK