ZYBIO - DRAP MDIR-0006521 (Class C)

DRAP REGISTERED MEDICAL DEVICE

ZYBIO (AFP Assay CLIA) [50T/Kit, 100T/Kit] is registered with DRAP under number MDIR-0006521 as a Class C (moderate to high risk) medical device, imported. The listed holder is Zybio Medical Pakistan (SMC-Private) Limited. It is listed as valid until 12 Mar 2029.

Screening result

i
Number type: imported, registered (Class B, C or D)
MDIR-0006521
✓
Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025
✓
Listed valid until 12 Mar 2029
i
Holder not found in DRAP's published licence list
That list covers manually issued licences only. Ask for a copy of the establishment licence.
DeviceZYBIO (AFP Assay CLIA) [50T/Kit, 100T/Kit]
ClassC
Listed holderZybio Medical Pakistan (SMC-Private) Limited
Holder addressHouse No 323, Street No. 66, Sector I-8/3, Islamabad
Manufacturing siteM/s Zybio Inc., Floor 1 to floor 5, building 30, No.6 of taikang road, block C of Jianqiao Industrial Park, Daduko District, 400082 Chongqing, PEOPLES'S REPUBLIC OF CHINA
Issued13 Mar 2024
Renewal date12 Mar 2029

Specifications

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Screened 4 Oct 2026, 23:52 (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-0001601Zybio DiluentClass A
MDIE-0001602Zybio Probe cleanserClass A
MDIE-0001603Zybio Hematology AnalyzerClass A
MDIE-0002070ZYBIO Chemistry Analyzer [EXC200 EXC220]Class A
MDIE-0002071ZYBIO Diluent kit [20 Lx1 Bucket, 10 Lx1 bucketClass A
MDIE-0002072ZYBIO Lyse kit [250mL/ Bottle 500mL/ Bottle]Class A
MDIE-0002073ZYBIO Lyse kit [Z5 LD) 500mL x 1]Class A
MDIE-0002074ZYBIO Nucleic Acid Isolation System [EXM3000]Class A
MDIE-0002075ZYBIO Nucleic Acid Isolation System [EXM6000]Class A
MDIE-0002076ZYBIO Blood Culture Bottle (Colorimetric Method) - Resin Anaerobic Bottle (AN) [20 Bottles/box 100 bottles/box]Class A
MDIR-0006502ZYBIO (PCT Asaay CLIA) [1x50T/Kit, 2x50T/Kit, 1x100T/Kit, 2x100T/Kit]Class C
MDIR-0006503ZYBIO (NT-proBNP Assay immunofluroscence) [25T/kit]Class C

Similar devices from other companies

Same device type listed by other holders, useful when comparing suppliers.

MDIE-0000964Zybio DILUENT Z5 DN, LYSE Z5 LD, LYSE Z5 LBClass AAyyan Moleculer Products
MDIE-0000965Zybio DILUENT, LYSE Blood cell dilution solution IVD, Blood cell lysis reagent IVDClass AAyyan Moleculer Products
MDIE-0000966Zybio HEMATOLOGY ANALYZER (Z3)Class AAyyan Moleculer Products
MDIE-0000967Zybio PROBE CLEANSERClass AAyyan Moleculer Products
MDIE-0000968Zybio Chemistry analyzer (EXC200)Class AAyyan Moleculer Products
MDIE-0000969Zybio HEMATOLOGY ANALYZER (Z50)Class AAyyan Moleculer Products
MDIR-0007907Zybio Nucleic acid detection kit (Magnetic Bead Method) [RNA/DNA Extraction Kit]Class BAyyan Moleculer Products
MDIR-0007908Zybio C- REACTIVE Protein Kit (immunoturbidimetric method)Class BAyyan Moleculer Products
MDIR-0007909Zybio Cluster for Liver functionClass BAyyan Moleculer Products
MDIR-0007910Zybio Cluster for SubstrateClass BAyyan 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.