FDA Registration Active 🇬🇧 United Kingdom

rMal d 4, (A796 Apple, Malus domestica)

Reg #: 3002806944 · FEI: 3002806944 · Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1

Registration Details

Registration Name
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED
Registration Number
3002806944
FEI Number
3002806944
Status
Active
Expiry Year
2025
Initial Importer
No
Address
GLYN RHONWY
City
LLANBERIS Wales
Country
GB

Regulatory Submissions

510(k) Number
K132801

Owner / Operator

Firm Name
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Operator Number
9096044
Address
Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
City
Tarrytown
State
NY
Postal Code
10591
Country
US
Correspondent
Mary Seeger

Products

Device Name Product Code
System, Test, Radioallergosorbent (Rast) Immunological DHB

Proprietary Names

rMal d 4, (A796 Apple, Malus domestica) rMal d 1 (A464 Apple, Malus domestica) rPru av 4 (A600 Cherry, Prunus avium) rBet v 2, (A127 Birch pollen, Betula verrucose) IMMULITE® 2000 3gAllergyTM Specific IgE Universal Kit rPru av 3, (A599 Cherry, Prunus avium) n Pru p 3, (A603 Peach, Prunus persica) rPru av 1, (A597 Cherry, Prunus avium)

Establishment Types

Manufacture Medical Device