Skin Test Reservoirs 8924ZA

GUDID 10365044000049

Holds testing antigens

Jubilant Hollisterstier LLC

Allergy testing lancet
Primary Device ID10365044000049
NIH Device Record Key2e692268-e62a-40f8-9c7a-509252f96c1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSkin Test Reservoirs
Version Model Number8924ZA
Catalog Number8924ZA
Company DUNS119241112
Company NameJubilant Hollisterstier LLC
Device Count30
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100365044000042 [Primary]
GS110365044000049 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDHSystem, Delivery, Allergen And Vaccine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-25
Device Publish Date2024-11-15

Devices Manufactured by Jubilant Hollisterstier LLC

10365044000001 - Quintest® Multiple Skin Test Device2024-11-25 Multiple skin test system with 5 testing legs/tines
10365044000018 - ComforTen® Multiple Skin Test System2024-11-25 Multiple skin test system with 10 testing legs/tines
10365044000025 - Quintip® Skin Test Device2024-11-25 Disposable self loading test system with 1 testing leg/tine
10365044000032 - Prick Lancetter™2024-11-25 1 testing leg/tine
10365044000049 - Skin Test Reservoirs2024-11-25Holds testing antigens
10365044000049 - Skin Test Reservoirs2024-11-25 Holds testing antigens
00365044000059 - ComforTen® 30-hole covered tray2024-11-25 30 hole test tray
00365044000066 - ComforTen® 60-hole covered tray2024-11-25 60 hole test tray
00365044000073 - Quintest® Covered Tray2024-11-25 60 hole covered test tray

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