DRAP REGISTERED MEDICAL DEVICE
Tina-quant Lambda & Kappa Gen. 2 (Cluster of Immunoglobulin) is registered with DRAP under number MDIR-0009944 as a Class B (low to moderate risk) medical device, imported. The listed holder is Roche Pakistan Ltd.. It is listed as valid until 25 Aug 2030.
Screening result
MDIR-0009944 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00009
| Device | Tina-quant Lambda & Kappa Gen. 2 (Cluster of Immunoglobulin) |
|---|---|
| Class | B |
| Listed holder | Roche Pakistan Ltd. |
| Holder address | 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400, Godown: R-Pl, Plot No. 56, Sector 15, K.I.A, Karachi |
| Manufacturing site | M/s Roche Diagnostics GmbH Sandhofer Str.116, 68305 Mannheim, Germany |
| Issued | 26 Aug 2025 |
| Renewal date | 25 Aug 2030 |
| Licence | ELI-00009 |
Specifications
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Screened 6 Oct 2026, 16:24 (Pakistan time). A screening aid, not an official DRAP verification.
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Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0001267 | Cobas Tina-Quant D-Dimer Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
Corrections
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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.
