DRAP REGISTERED MEDICAL DEVICE
Alinity c Dibucaine (CHE) Reagent Kit, Alinity c Cholinesterase Reagent Kit, Alinity c Clinical Chemistry Control 1 Kit, Alinity c Clinical Chemistry Control 2 Kit is registered with DRAP under number MDIR-0002396 as a Class B (low to moderate risk) medical device, imported. The listed holder is Abbott Laboratories(Pakistan) Ltd. Its listed renewal date (28 Mar 2026) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0002396
DRAP registered Class B/C/D list, 28 Aug 2025
It may have been renewed after DRAP's last list. Ask the vendor for the renewal letter.
ELI-00019
| Device | Alinity c Dibucaine (CHE) Reagent Kit, Alinity c Cholinesterase Reagent Kit, Alinity c Clinical Chemistry Control 1 Kit, Alinity c Clinical Chemistry Control 2 Kit |
|---|---|
| Class | B |
| Listed holder | Abbott Laboratories(Pakistan) Ltd |
| Holder address | Opposite Radio Pakistan Transmission Center, Hyderabad Road, Landhi, Karachi |
| Manufacturing site | M/s Sentinel CH, Spa Via Robert Koch 2-20152 Milano, Italy |
| Issued | 29 Mar 2021 |
| Renewal date | 28 Mar 2026 |
| Licence | ELI-00019 |
Specifications
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Screened 5 Oct 2026, 08:41 (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 |
| MDIE-0000227 | Determine Chase Buffer Code: 7D2243 | Class A |
| 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 |
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.
