Data / Medical devices / Allergen And Vaccine Delivery Needles
Allergen And Vaccine Delivery Needles (SCL): 13 FDA-registered makers in 4 countries
13 establishments in 4 countries are registered with the FDA to make Allergen And Vaccine Delivery Needles (product code SCL, Class 2, 21 CFR 880.5570). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 25 510(k) clearances under this code, the latest on January 30, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- SCL
- Device class
- 2
- Regulation
- 880.5570
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| China | 3 |
| United Kingdom | 1 |
| Turkey | 1 |
Makers of Allergen And Vaccine Delivery Needles
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Lincoln Diagnostics, Inc. | Decatur, IL, United States | Manufacturer | 3 | August 7, 1996 | 0 | 0 | 0 | api.fda.gov |
| Roechling Medical Lancaster, LLC | Denver, PA, United States | Manufacturer | 2 | August 7, 2003 | 0 | 0 | 0 | api.fda.gov |
| Alkaline Corp. | Eatontown, NJ, United States | Manufacturer | 1 | February 8, 1985 | 0 | 0 | 0 | api.fda.gov |
| Allergy & Applicator Depot, LLC | Manorville, NY, United States | Specification developer | 1 | April 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang Anhui, China | Manufacturer | 1 | December 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Greer Laboratories, Inc. | Lenoir, NC, United States | Manufacturer, Specification developer | 1 | June 23, 1989 | 0 | 0 | 0 | api.fda.gov |
| Jubilant Hollisterstier LLC | Spokane, WA, United States | Manufacturer, Specification developer | 1 | November 13, 1995 | 0 | 0 | 0 | api.fda.gov |
| Medscience Research Group, Inc. | West Palm Beach, FL, United States | Specification developer | 1 | March 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Procare Industrial Co., Limited | ZHENGZHOU Henan, China | Manufacturer | 1 | August 17, 2017 | 0 | 0 | 0 | api.fda.gov |
| BioGeniv, INC | Lenoir, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Shun King Company Limited | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Entaco Ltd. | Redditch Worcestershire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yilmaz Bio Medikal | gaziantep, Turkey | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.