Sure-Vue 23038006

GUDID 00613647001301

SURE-VUE MONO 50 TESTS

FISHER SCIENTIFIC COMPANY L.L.C.

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination
Primary Device ID00613647001301
NIH Device Record Key027163ae-df4f-4b39-bd3a-6117640f9c1a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSure-Vue
Version Model NumberT3018-1001
Catalog Number23038006
Company DUNS004321519
Company NameFISHER SCIENTIFIC COMPANY L.L.C.
Device Count50
DM Exempttrue
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-Counterfalse

Customer Support Contacts

Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613647001301 [Primary]
GS110613647001308 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTNSYSTEM, TEST, INFECTIOUS MONONUCLEOSIS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Sure-Vue]

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

Trademark Results [Sure-Vue]

Mark Image

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