Medicine
Vistaseal kit
Vistaseal kit is a prescription medicine containing Human fibrinogen, marketed by Grifols, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store the frozen kit (VISTASEAL fibrin sealant (human) with VISTASEAL Dual…
Key facts
- Active ingredient (INN)
- Human fibrinogen
- Brand
- Vistaseal
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Grifols
- Manufacturer
- Grifols
- Origin register
- US FDA, United States
- Storage
- Store the frozen kit (VISTASEAL fibrin sealant (human) with VISTASEAL Dual Applicator) in a freezer (at -18 °C [0 ºF] or colder) for up to 2 years. After thawing, VISTASEAL can be stored before use for not more than 7 days at 2 - 8 °C [36 - 46 °F] or 24 hours at room temperature (20 - 25 °C [68 - 77 °F]) if it remains sealed in the original packaging (blister).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B02BB01 Fibrinogen
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 November 2019
- Identifiers
- RxCUI 2264366, 2264371, 2264603 +5DailyMed set ID a8708417-2f74-4dfa-b6f9-ef88f902e0fcNDC 61953-0011, 61953-0014, 61953-0012Application BLA125640
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 kit in 1 package, combination * 1 mL in 1 syringe, glass * 1 mL in 1 syringe, glass | 61953-0011-1 | Grifols | 1 November 2019 |
| 1 kit in 1 package, combination * 2 mL in 1 syringe, glass * 2 mL in 1 syringe, glass | 61953-0012-1 | Grifols | 1 November 2019 |
| 1 kit in 1 package, combination * 5 mL in 1 syringe, glass * 5 mL in 1 syringe, glass | 61953-0014-1 | Grifols | 1 November 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Human fibrinogen is a prescription medicine. It is available as kits. MedsAcross supplies Human fibrinogen for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Human fibrinogenFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- VISTASEAL prescribing information (Grifols) · U.S. National Library of Medicine, DailyMed
Need Vistaseal kit for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.