DRAP REGISTERED MEDICAL DEVICE
Alinity m CMV CAL Kit 09N46-070 [Alinity m CMV CTRL Kit 09N46-080 Alinity m CMV AMP Kit 09N46-090] is registered with DRAP under number MDIR-0005708 as a Class C (moderate to high risk) medical device, imported. The listed holder is Abbott Laboratories(Pakistan) Ltd. It is listed as valid until 24 Oct 2028.
Screening result
MDIR-0005708
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00019
| Device | Alinity m CMV CAL Kit 09N46-070 [Alinity m CMV CTRL Kit 09N46-080 Alinity m CMV AMP Kit 09N46-090] |
|---|---|
| Class | C |
| Listed holder | Abbott Laboratories(Pakistan) Ltd |
| Holder address | Opposite Radio Pakistan Transmission Center, Hyderabad Road, Landhi, Karachi. |
| Manufacturing site | M/s Abbott Molecular Inc 1300 East Touhy Avenue Des Plaines, IL 60018 USA |
| Issued | 25 Oct 2023 |
| Renewal date | 24 Oct 2028 |
| Licence | ELI-00019 |
Specifications
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Screened 4 Oct 2026, 22:10 (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-0000226 | Alinity c Processing Module and ICT module (cluster) | Class A |
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| MDIE-0000254 | Alinity I Processing Module [03R6501] | Class A |
| MDIE-0000284 | Pima Analyzer [260300003] | Class A |
| MDIE-0000285 | m-Pima Analyzer [27030R001] | Class A |
| MDIE-0000302 | Alinity hq Analyzer [09P68-01] | Class A |
| MDIE-0000303 | Alinity s System [06P16-01] | Class A |
| MDIE-0000307 | Alinity s Concentrated Wash Buffer [06P1388] | Class A |
| MDIE-0000425 | Cell-Dyn Emerald 22 AL Instrument [04R13-01] | Class A |
| MDIE-0000426 | Cell-Dyn Sapphire [08H00-01] | Class A |
| MDIE-0000427 | AFINION 2 Analyzer [1116770] | Class A |
| MDIE-0000428 | NYCOCARD Reader II [1116815] | Class A |
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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.
