Sure-Vue 23900531

GUDID 00613647000533

SURE-VUE HCG STAT SER/UR 50/PK

FISHER SCIENTIFIC COMPANY L.L.C.

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

Primary Device ID	00613647000533
NIH Device Record Key	3fa0f5bb-06f8-4fac-a975-7761a8d22c4d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sure-Vue
Version Model Number	4581405021
Catalog Number	23900531
Company DUNS	004321519
Company Name	FISHER SCIENTIFIC COMPANY L.L.C.
Device Count	50
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613647000533 [Primary]
GS1	10613647000530 [Unit of Use]

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	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

Trademark Results [Sure-Vue]

Mark Image Registration \| Serial	Company Trademark Application Date
SURE-VUE 75878442 2535492 Live/Registered	Fisher Scientific Company L.L.C. 1999-12-22