FDA.reportPublic FDA data

AllergiEnd ST-9

Primary DI
B68210010
Brand
AllergiEnd ST-9
Company
MEDSCIENCE RESEARCH GROUP, INC.
Model
1001
Catalog number
1001
Device description
72 Well Test Tray
Published
2018-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
B68210010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General laboratory assay trayA tray with multiple wells designed to contain volumes of reagents, buffers, and other materials for laboratory testing procedures (e.g., in vitro diagnostic) performed manually, or by a laboratory analyser. The wells may in addition be used to contain and mix reactants for reactions performed onboard the analyser. It is typically made of plastic (e.g., polypropylene) and is used with manual or automated liquid handling instruments or analysers. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Fahrenheit140 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
B68210000AllergiEnd ST-9100010002018-11-30
B682100040AllergiEnd ST-9 1000-41000-42018-11-30
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
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