DRAP REGISTERED MEDICAL DEVICE
IVD Test Kit of Tina-quant Cystatin C Gen2 (CYSC 2) is registered with DRAP under number MDIR-0004459 as a Class B (low to moderate risk) medical device, imported. The listed holder is Roche Pakistan Ltd.. It is listed as valid until 29 Dec 2027.
Screening result
MDIR-0004459 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00009
| Device | IVD Test Kit of Tina-quant Cystatin C Gen2 (CYSC 2) |
|---|---|
| Class | B |
| Listed holder | Roche Pakistan Ltd. |
| Holder address | 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| Manufacturing site | M/s Roche Diagnostics GmbH Sandhofer Str.116, 68305 Mannheim, Germany M/s Roche Diagnostics GmbH Sandhofer Str.116, 68305 Mannheim, Germany |
| Issued | 30 Dec 2022 |
| Renewal date | 29 Dec 2027 |
| Licence | ELI-00009 |
Specifications
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Screened 6 Oct 2026, 17:59 (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.