Manufacturer profile
Sure Bio Diagnostics & Pharmaceuticals
Manufacturer snapshot
Overview of registrations for this manufacturer
17
Total Registrations
17
Distinct Products
6/16/2023
Latest Registration
5/17/2021
Earliest
Risk class distribution
Risk C8
Risk D3
Risk B6
Registrations (17)
Click a registration number to view details
Terumo BCT Inc.
Anticoagulant
Citrate Dextrose
Solution
[750ml Cat# 40818]6/16/2023
Registration: MDIR-0005214
Risk Class: C
Expires: 6/15/2028
Ortho BioVue System
[Anti-Human Globulin
Anti-IgG, -C3d;
polyspecific]
Poly Cassette
[707300 (400
cassettes)
707350 (100
cassettes)]10/11/2022
Registration: MDIR-0003794
Risk Class: D
Expires: 10/10/2027
Ortho
0.8% Affirmagen
Reagent
(Reagent Red Blood
Cells)
[719202]10/11/2022
Registration: MDIR-0003795
Risk Class: D
Expires: 10/10/2027
Syphilis Ab One
version ULTRA ELISA10/11/2022
Registration: MDIR-0003796
Risk Class: D
Expires: 10/10/2027
Spectra Optia
Collection Set
[12120]10/11/2022
Registration: MDIR-0003797
Risk Class: C
Expires: 10/10/2027
Spectra Optia
Exchange Set10/11/2022
Registration: MDIR-0003798
Risk Class: B
Expires: 10/10/2027
Reveos Automated
Blood Processing
System [Automated
Blood Processing
System]10/11/2022
Registration: MDIR-0003799
Risk Class: B
Expires: 10/10/2027
COBE Spectra
Dual Needle Extended
Life Platelet Set with
LRS Chamber
(Platelet collection
Needle)10/11/2022
Registration: MDIR-0003800
Risk Class: C
Expires: 10/10/2027
Spectra Optia IDL Set
[12320, 10310]10/11/2022
Registration: MDIR-0003806
Risk Class: C
Expires: 10/10/2027
Terumo BCT Inc.
Anticoagulant
Citrate Dextrose
Solution
[750ml Cat# 40800]10/11/2022
Registration: MDIR-0003807
Risk Class: C
Expires: 10/10/2027
Spectra Optia
Apheresis System10/11/2022
Registration: MDIR-0003801
Risk Class: B
Expires: 10/10/2027
Spectra Optia
Collection Set
[10120]10/11/2022
Registration: MDIR-0003802
Risk Class: C
Expires: 10/10/2027
Spectra Optia
BMP Accessory set
[11300]10/11/2022
Registration: MDIR-0003803
Risk Class: C
Expires: 10/10/2027
Spectra Optia
Platelet, Plasma Set
[10400]10/11/2022
Registration: MDIR-0003804
Risk Class: C
Expires: 10/10/2027
Spectra Optia
Exchange Set
[10220]10/11/2022
Registration: MDIR-0003805
Risk Class: B
Expires: 10/10/2027
AccuDiag
Chikungunya IgG/ IgM
Elisa Cluster
[8112-25, 8113-25]1/6/2022
Registration: MDIR-0003129
Risk Class: B
Expires: 1/5/2027
Amphetamine Urine
RapidDip, Barbiturate
Urine RapiDip Insta
Test, Benzodiazepine
Urine RapiDip
InstaTest,
Methamphetamine
Urine RapiDip
InstaTest, Marijuana
Urine RapiDip Insta
Test,
Opiates/Heroin/Morphi
ne Urine RapiDip Insta
Test5/17/2021
Registration: MDIR-0002508
Risk Class: B
Expires: 5/16/2026
About this profile
Access the DRAP portfolio for Sure Bio Diagnostics & Pharmaceuticals via Pure Global AI. This manufacturer holds 17 registrations across 17 distinct products, with registrations ranging from 5/17/2021 to 6/16/2023 and spanning 3 risk classes.
This mirrors the Brazil holder experience with a concise snapshot and direct links to each DRAP registration.
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