FDA.reportPublic FDA data

ComforTen® Multiple Skin Test System

Primary DI
00365044000011
Brand
ComforTen® Multiple Skin Test System
Company
Jubilant Hollisterstier LLC
Model
80000000021
Catalog number
80000000021
Device description
Multiple skin test system with 10 testing legs/tines
Published
2024-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDHSystem, Delivery, Allergen And Vaccine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDHSystem, Delivery, Allergen And Vaccine

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953939000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953939000QUINTESTBayer Corp.1995-11-13SCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00365044000011PrimaryGS10
10365044000018Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00365044000011003650440000113650440000110365044000011
1036504400001810365044000018

GMDN Terms#

Term, Definition table
TermDefinition
Allergy testing lancetA sterile device with a sharp triangular cutting edge at the distal end designed to manually breach the epidermis to facilitate the diagnosis of allergic reactions in skin allergy testing performed by an allergist or other healthcare professional. It is held between the fingertips and pressed transiently, but firmly (not jabbed), at right angles through a drop of an allergen extract into the flexor side of the forearm of a suspected allergic individual. The tip penetrates only the most superficial layers of the skin allowing a small volume of the allergen extract to enter the skin and diffuse into the skin layers below. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
800.495.7437HollisterStier@jubl.com

Regulatory Flags#

DUNS number
119241112
Device count
3
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00365044000080ComforTen® 60-hole covered tray800000137280000013722026-03-02
00365044000004Quintest® Multiple Skin Test Device8392ZA8392ZA2024-11-15
00365044000028Quintip® Skin Test Device8400ZA8400ZA2024-11-15
00365044000035Prick Lancetter™8375ZA8375ZA2024-11-15
00365044000042Skin Test Reservoirs8924ZA8924ZA2024-11-15
10365044000001Quintest® Multiple Skin Test Device8392ZA8392ZA2024-11-15
10365044000018ComforTen® Multiple Skin Test System80000000021800000000212024-11-15
10365044000025Quintip® Skin Test Device8400ZA8400ZA2024-11-15
10365044000032Prick Lancetter™8375ZA8375ZA2024-11-15
10365044000049Skin Test Reservoirs8924ZA8924ZA2024-11-15
00365044000059ComforTen® 30-hole covered tray8406ZA8406ZA2024-11-15
00365044000066ComforTen® 60-hole covered tray8407ZA8407ZA2024-11-15
00365044000073Quintest® Covered Tray8930ZA8930ZA2024-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00365044000004Quintest® Multiple Skin Test DeviceJubilant Hollisterstier LLCLDH2024-11-15
00365044000028Quintip® Skin Test DeviceJubilant Hollisterstier LLCLDH2024-11-15
00365044000035Prick Lancetter™Jubilant Hollisterstier LLCLDH2024-11-15
00365044000042Skin Test ReservoirsJubilant Hollisterstier LLCLDH2024-11-15
10365044000001Quintest® Multiple Skin Test DeviceJubilant Hollisterstier LLCLDH2024-11-15
10365044000018ComforTen® Multiple Skin Test SystemJubilant Hollisterstier LLCLDH2024-11-15
10365044000025Quintip® Skin Test DeviceJubilant Hollisterstier LLCLDH2024-11-15
10365044000032Prick Lancetter™Jubilant Hollisterstier LLCLDH2024-11-15
10365044000049Skin Test ReservoirsJubilant Hollisterstier LLCLDH2024-11-15
00365044000059ComforTen® 30-hole covered trayJubilant Hollisterstier LLCLDH2024-11-15
00365044000066ComforTen® 60-hole covered trayJubilant Hollisterstier LLCLDH2024-11-15
00365044000073Quintest® Covered TrayJubilant Hollisterstier LLCLDH2024-11-15
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ALK80001AccuTest-1™MEDSCIENCE RESEARCH GROUP, INC.LDH2024-04-16
B682ALK08H006AccuTest-8™MEDSCIENCE RESEARCH GROUP, INC.LDH2024-03-15
B682ALK10H006AccuTest-10™MEDSCIENCE RESEARCH GROUP, INC.LDH2024-03-15
B682ALK48T001AccuTest™ Test TrayMEDSCIENCE RESEARCH GROUP, INC.LDH2024-03-15
B682ALK60T001AccuTest™ Test TrayMEDSCIENCE RESEARCH GROUP, INC.LDH2024-03-15
B682ALK8002AccuTest-1™MEDSCIENCE RESEARCH GROUP, INC.LDH2024-03-15
00300858999991BCG Vaccine (Multiple Puncture Device)Merck Sharp & Dohme LLCLDH2023-04-10
60300858999993BCG Vaccine (Multiple Puncture Device)MERCK SHARP & DOHME CORP.LDH2023-04-10
B6828002ST-9MEDSCIENCE RESEARCH GROUP, INC.LDH2021-09-30
B68280021ST-9MEDSCIENCE RESEARCH GROUP, INC.LDH2021-09-30
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10854498007372SmartPracticeSmarthealth, Inc.LDH2020-12-15
10854498007389SmartPracticeSmarthealth, Inc.LDH2020-12-15
00854498007399SmartPracticeSmarthealth, Inc.LDH2020-12-15
10854498007402SmartPracticeSmarthealth, Inc.LDH2020-12-15