S-BIO Anti B - Indonesia BPOM Medical Device Registration
S-BIO Anti B is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209817254. The device is manufactured by TULIP DIAGNOSTICS (P) LTD from India, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is ZEFINDO DARYA MEGATAMA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
TULIP DIAGNOSTICS (P) LTDCountry of Origin
India
Authorized Representative
ZEFINDO DARYA MEGATAMAAR Address
Jl. Jemursari No 329-331 B, Kode Pos 60239, Desa/Kelurahan Sidosermo, Kec. Wonocolo, Kota Surabaya, Prov. Jawa Timur
Registration Date
Dec 04, 2023
Expiry Date
May 31, 2025
Product Type
Products used in the manufacture of blood preparations and preparations of origin and blood
Blood group substances of nonhuman origin for in vitro diagnostic use.
Invitro Diagnostics
ERYBANK Bovine Serum Albumin
ERYCARD 2.0
INSIGHT DOA PANEL 6.1 DEVICE
DALF IT Salmonella Flagellar Antigen HA Paratyphi
DALF IT Salmonella Flagellar Antigen HB Paratyphi
DALF IT Salmonella Flagellar Antigen HD Typhi
DALF IT Salmonella Somatic Antigen OA Paratyphi
DALF IT Salmonella Somatic Antigen OD Typhi
DALF IT Salmonella Flagellar Antigen HC Paratyphi
DALF IT Salmonella Somatic Antigen OB Paratyphi
HOTGEN Procalcitonin test (Chemiluminescence Immunoassay)
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HOTGEN Thyroxine test (Chemiluminescence Immunoassay)
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HOTGEN C-reactive protein test (Chemiluminescence Immunoassay)
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