首页»EN»EN | 波音特 · 体外诊断试剂供应与出口合作
Biot · IVD Reagents for Global Laboratories
Biot Technology (Nanjing) Co., Ltd. supplies biochemical reagents and detection kits for in-vitro diagnostics. This English overview page introduces our product directions, quality approach and cooperation models for overseas distributors, clinical laboratories and OEM partners.
Product Portfolio at a Glance
Five clinical directions covered by our reagent menu — renal function, gastric function, cardiac markers, infection markers and glucose metabolism. Each kit is supplied with a technical data sheet, calibration guidance and lot-level COA on request.
Creatinine Kit
Enzymatic method for serum and urine creatinine, suited to automated chemistry analyzers.
Pepsinogen I / II
Latex-enhanced immunoturbidimetry for gastric mucosal risk screening panels.
HbA1c Kit
Glycated hemoglobin measurement supporting long-term glycemic monitoring programs.
Myoglobin Kit
Latex immunoturbidimetric assay for early cardiac marker evaluation.
Procalcitonin Kit
Infection marker reagent supporting sepsis risk stratification workflows.
OEM & Private Label
Custom packaging, bilingual IFU and label design for distributor brands.
Why Laboratories Choose Biot
- Reagent formulations validated on mainstream open chemistry analyzers.
- Stable lot-to-lot performance with traceable QC documentation.
- English technical files, MSDS and COA available for registration.
- Flexible MOQ and lead time for trial orders before scale-up.
- Dedicated export coordinator answering within one business day.
Cooperation Workflow
A simple three-step path from first inquiry to repeat order — designed for distributors who need predictable documentation and delivery.
STEP 01
Inquiry & Matching
Share your analyzer model and target menu; we confirm compatible kit formats and pack sizes.
STEP 02
Sample & Documents
Trial samples ship with English IFU, MSDS and COA so your registration team can review early.
STEP 03
Order & Replenish
Confirm batch quantity, packaging language and shipping schedule; repeat orders follow the same lot logic.
Frequently Asked by Overseas Partners
Can we request English IFU before ordering?
Yes. English instruction files and technical data sheets are provided during the sample stage.
Do you support private label packaging?
Private label and OEM packaging are available with agreed minimum quantities and label artwork review.
How are reagents shipped?
Cold-chain or ambient packing is selected according to product stability requirements and destination climate.
Latest Articles & Related Reading
行业新闻 · 2026-11-01
国家药监局关于印发医疗器械生产质量管理规范检查指导原则的通知
各省、自治区、直辖市和新疆生产建设兵团药品监督管理局: 新修订《医疗器械生产质量管理规范》(以下简称《规范》)自2026年11月1日起施行。为更好地指导各级药品监督管理部门开展医疗器械生产检查工作,国家药监局组织对《医疗器械生产质量管理规范
Read more →
行业新闻 ·
血管内超声诊断设备、一次性使用血管内超声诊断导管获批上市
近日,国家药品监督管理局批准了深圳皓影医疗科技有限公司的血管内超声诊断设备、一次性使用血管内超声诊断导管注册申请。 血管内超声诊断设备由成像主机(含推车、触摸显示器、键盘、鼠标)和旋转回撤装置组成。一次性使用血管内超声诊断导管由血管内超声诊
Read more →
行业新闻 ·
全过程覆盖 全链条闭环 医疗器械上市后变更管理更加科学精细
2025年11月,国家药监局发布新修订《医疗器械生产质量管理规范》(以下简称新版规范)。新版规范对我国医疗器械生产质量管理体系进行了全面升级,标志着我国医疗器械监管迈入新阶段。 在变更管理方面,新版规范将变更控制贯穿质量管理体系全过程,使其
Read more →
行业新闻 ·
河北开展医疗器械生产企业穿透式检查
近日,河北省药监局组织对5家医疗器械生产企业开展穿透式检查,通过链条穿透、数据穿透、要素穿透等方式,挖掘在日常监管中不易被发现的问题。检查范围涵盖体外诊断试剂、无菌植入类医疗器械、集采中选品种等风险较高、具有一定代表性的医疗器械生产企业。
Read more →
行业新闻 ·
医疗器械分类调整工作进一步优化
近日,《国家药监局关于医疗器械分类调整有关工作的公告》(以下简称《分类调整公告》)、《国家药监局关于发布医疗器械分类目录动态调整工作程序的公告》正式发布。上述文件将更好地指导医疗器械分类调整工作,进一步优化医疗器械分类目录动态调整工作程序。
Read more →
行业新闻 ·
山东省药监局第六分局开展医疗器械生产环节风险隐患排查整治工作
近日,山东省药监局区域检查第六分局围绕产品质量安全与生产安全两大重点,部署开展医疗器械生产环节风险隐患排查整治专项工作,严守医疗器械质量安全与生产安全底线,压实企业主体责任,切实保障群众用械安全。 本次排查整治坚持问题导向、靶向监管,紧盯生
Read more →
Ready to Discuss Your Reagent Menu?
Send your analyzer model, target parameters and annual volume — our export team will reply with a tailored quotation.
Send an Inquiry