FDA.reportPublic FDA data

AllergiEnd ST-9

Primary DI
B68210000
Brand
AllergiEnd ST-9
Company
MEDSCIENCE RESEARCH GROUP, INC.
Model
1000
Catalog number
1000
Device description
The AllergiEnd ST-9 Multiple skin Test Applicator has nine (9) test heads arranged in an asymmetrical design two (2) rows of four (4) test heads and a distal ninth test head. The test heads are labeled 1 through 9.
Published
2018-11-30
Public version status
Update
Distribution status
Not 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
K172062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172062000AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test TrayMedscience Science Research Group, Inc.2018-03-05SCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B68210000PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit150 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5614990411marvin.smollar@medscienceinc.c
5614990411marvin.smollar@medscienceinc.com
561-459-3919liz.magdaleno@medscienceinc.com

Regulatory Flags#

DUNS number
013114656
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B682ALK8004AccuTest-1™ALK80042024-04-16
B682100012ST-9ST-9 1000-12ST-9 1000-122018-11-30
B6828002ST-9ST-9 8002ST-9 80022021-09-30
B682ALK08H006AccuTest-8™ALK08H-006ALK08H-0062024-03-15
B682ALK10H006AccuTest-10™ALK10H-006ALK10H-0062024-03-15
B682ALK48T001AccuTest™ Test TrayALK48T-001ALK48T-0012024-03-15
B682ALK8002AccuTest-1™ALK8002ALK80022024-03-15
B682100040AllergiEnd ST-9 1000-41000-42018-11-30
B68210010AllergiEnd ST-9100110012018-11-30
B6821001360AllergiEnd ST-91001-361001-362018-11-30
B682ALK60T001AccuTest™ Test TrayALK60T-001ALK60T-0012024-03-15
ALK80001AccuTest-1™ALK80042024-04-16
B68280021ST-9800280022021-09-30
B6821000121AllergiEnd ST-91000-121000-122018-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00365044000004Quintest® Multiple Skin Test DeviceJubilant Hollisterstier LLCLDH2024-11-15
00365044000011ComforTen® Multiple Skin Test SystemJubilant 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
B682ALK8004AccuTest-1™MEDSCIENCE RESEARCH GROUP, INC.LDH2024-04-16
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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10854498007266SmartPracticeSmarthealth, Inc.LDH2020-12-15
10854498007365SmartPracticeSmarthealth, Inc.LDH2020-12-15
10854498007372SmartPracticeSmarthealth, Inc.LDH2020-12-15
10854498007389SmartPracticeSmarthealth, Inc.LDH2020-12-15
00854498007399SmartPracticeSmarthealth, Inc.LDH2020-12-15