ST-9 8002
GUDID B68280021
Allergy Testing Lancet
MEDSCIENCE RESEARCH GROUP, INC.
Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet Allergy testing lancet| Primary Device ID | B68280021 |
| NIH Device Record Key | 95206e99-1d32-40aa-b943-47f49b082b68 |
| Commercial Distribution Discontinuation | 2025-10-30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ST-9 |
| Version Model Number | 8002 |
| Catalog Number | 8002 |
| Company DUNS | 013114656 |
| Company Name | MEDSCIENCE RESEARCH GROUP, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B68280021 [Primary] |
| HIBCC | B682800217202103 [Package] Package: Bag [36 Units] Discontinued: 2025-10-30 In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172062
FDA Product Code
| LDH | System, Delivery, Allergen And Vaccine |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-08 |
| Device Publish Date | 2021-09-30 |
Devices Manufactured by MEDSCIENCE RESEARCH GROUP, INC.
| ALK80001 - AccuTest-1™ | 2024-04-24 1 box of 12 Items ALK8002 that contains 432 single head applicators |
| B682ALK08H006 - AccuTest-8™ | 2024-03-25 8 Head Multiple-Skin Testing Applicators packed 6 to the vacuum tray |
| B682ALK10H006 - AccuTest-10™ | 2024-03-25 10 Head multiple-skin testing applicators packed 6 to the vacuum tray |
| B682ALK48T001 - AccuTest™ Test Tray | 2024-03-25 48 Multiple well test tray |
| B682ALK60T001 - AccuTest™ Test Tray | 2024-03-25 60 Multiple well test tray |
| B682ALK8002 - AccuTest-1™ | 2024-03-25 36 Single head applicators packed as 4 sets of 9 single head applicators per set |
| B68280021 - ST-9 | 2021-10-08Allergy Testing Lancet |
| B68280021 - ST-9 | 2021-10-08 Allergy Testing Lancet |
| B68210010 - AllergiEnd ST-9 | 2019-01-08 72 Well Test Tray |
Trademark Results [ST-9]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ST-9 88580390 not registered Live/Pending |
ST-9, Inc. 2019-08-15 |
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