DRAP registered medical device · imported

Ortho BioVue System [Anti-Human Globulin Anti-IgG, -C3d; polyspecific] Poly Cassette [707300

Class D (high risk) · MDIR-0003794 · Sure Bio Diagnostics & Pharmaceuticals

✓ DRAP status Listed Valid until 10 Oct 2027

Screened against DRAP's published lists

DRAP REGISTERED MEDICAL DEVICE

Ortho BioVue System [Anti-Human Globulin Anti-IgG, -C3d; polyspecific] Poly Cassette [707300 (400 cassettes) 707350 (100 cassettes)] is registered with DRAP under number MDIR-0003794 as a Class D (high risk) medical device, imported. The listed holder is Sure Bio Diagnostics & Pharmaceuticals. It is listed as valid until 10 Oct 2027.

Screening result

Imported device, registered with DRAP as Class D (high risk)
MDIR-0003794 · the class is taken from DRAP's list for this number

✓

Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025

✓

Listed valid until 10 Oct 2027

✓

Holder has a DRAP import licence on file
ELI-00084

Device	Ortho BioVue System [Anti-Human Globulin Anti-IgG, -C3d; polyspecific] Poly Cassette [707300 (400 cassettes) 707350 (100 cassettes)]
Class	D
Listed holder	Sure Bio Diagnostics & Pharmaceuticals
Holder address	EE -10 Defence View Phase II, Near Iqra University Shaheed-e-Millat Express Way, Karachi
Manufacturing site	M/s Ortho-Clinical Diagnostics, Inc. Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, United Kingdom. M/s Ortho-Clinical Diagnostics, Inc. 1001 US Highway 202 Raritan NJ 08869-0606 USA
Issued	11 Oct 2022
Renewal date	10 Oct 2027
Licence	ELI-00084

Specifications

No supplier specifications yet.

Supplier of this device? Add specifications (free during launch)

Screened 7 Oct 2026, 03:21 (Pakistan time). A screening aid, not an official DRAP verification.

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Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.