FDA.reportPublic FDA data

AccuTest-1™

Primary DI
ALK80001
Brand
AccuTest-1™
Company
MEDSCIENCE RESEARCH GROUP, INC.
Model
ALK8004
Device description
1 box of 12 Items ALK8002 that contains 432 single head applicators
Published
2024-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
B682ALK8004PrimaryHIBCC0
ALK80001Unit of UseHIBCC0

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
561-515-5995liz.magdaleno@medscienceinc.com
561-459-3919liz.magdaleno@medscienceinc.com

Regulatory Flags#

DUNS number
013114656
Device count
12
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
B68210000AllergiEnd ST-9100010002018-11-30
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
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
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
10854498007242SmartPracticeSmarthealth, Inc.LDH2020-12-15
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
10854498007402SmartPracticeSmarthealth, Inc.LDH2020-12-15