DRAP ENLISTED MEDICAL DEVICE
ZYBIO Lyse kit [250mL/ Bottle 500mL/ Bottle] is enlisted with DRAP under number MDIE-0002072 as a Class A (low risk) medical device, imported. The listed holder is Zybio Medical Pakistan (SMC-Private) Limited. It is listed as valid until 18 Jul 2030.
Screening result
MDIE-0002072 · the class is taken from DRAP's list for this number
DRAP enlisted Class A list, 28 Aug 2025
That list covers manually issued licences only. Ask for a copy of the establishment licence.
| Device | ZYBIO Lyse kit [250mL/ Bottle 500mL/ Bottle] |
|---|---|
| Class | A |
| Listed holder | Zybio Medical Pakistan (SMC-Private) Limited |
| Holder address | House No 323, Street No. 66, Sector I-8/3, Islamabad |
| Manufacturing site | M/s Zybio Inc No. 45, Shilin Avenue, Tiaodeng Town, Dadukou District, 400082 Chongqing, People's Republic of China |
| Issued | 19 Jul 2025 |
| Renewal date | 18 Jul 2030 |
Specifications
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Screened 5 Oct 2026, 21:09 (Pakistan time). A screening aid, not an official DRAP verification.
More devices from this holder
Other DRAP registrations and enlistments listed for the same company.
| MDIE-0001601 | Zybio Diluent | Class A |
| MDIE-0001602 | Zybio Probe cleanser | Class A |
| MDIE-0001603 | Zybio Hematology Analyzer | Class A |
| MDIE-0002070 | ZYBIO Chemistry Analyzer [EXC200 EXC220] | Class A |
| MDIE-0002071 | ZYBIO Diluent kit [20 Lx1 Bucket, 10 Lx1 bucket | Class A |
| MDIE-0002073 | ZYBIO Lyse kit [Z5 LD) 500mL x 1] | Class A |
| MDIE-0002074 | ZYBIO Nucleic Acid Isolation System [EXM3000] | Class A |
| MDIE-0002075 | ZYBIO Nucleic Acid Isolation System [EXM6000] | Class A |
| MDIE-0002076 | ZYBIO Blood Culture Bottle (Colorimetric Method) - Resin Anaerobic Bottle (AN) [20 Bottles/box 100 bottles/box] | Class A |
| MDIR-0006502 | ZYBIO (PCT Asaay CLIA) [1x50T/Kit, 2x50T/Kit, 1x100T/Kit, 2x100T/Kit] | Class C |
| MDIR-0006503 | ZYBIO (NT-proBNP Assay immunofluroscence) [25T/kit] | Class C |
| MDIR-0006504 | ZYBIO (Troponin T/CK-MB/Myoglobin Assay immunofluroscence) [1x25T/Kit, 2x25T/Kit, 4x25T/Kit, 6x25T/Kit, 8x25T/Kit] | Class C |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIE-0000964 | Zybio DILUENT Z5 DN, LYSE Z5 LD, LYSE Z5 LB | Class A | Ayyan Moleculer Products |
| MDIE-0000965 | Zybio DILUENT, LYSE Blood cell dilution solution IVD, Blood cell lysis reagent IVD | Class A | Ayyan Moleculer Products |
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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.