DRAP REGISTERED MEDICAL DEVICE
04T8520 Amylase2 (For Alinity c Instrument) is registered with DRAP under number MDIR-0008301 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 5 May 2030.
Screening result
MDIR-0008301 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00019
| Device | 04T8520 Amylase2 (For Alinity c Instrument) |
|---|---|
| Class | C |
| Listed holder | Abbott Laboratories(Pakistan) Ltd |
| Holder address | Opposite Radio Pakistan Transmission Center, Hyderabad Road, Landhi, Karachi. |
| Manufacturing site | M/s Abbott Ireland Diagnostics Division Lisnamuck, Longford Co. Longford, Ireland |
| Issued | 6 May 2025 |
| Renewal date | 5 May 2030 |
| Licence | ELI-00019 |
Specifications
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Screened 5 Oct 2026, 18:38 (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 |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0009029 | BIOSYSTEMS Alpha Amylase (DIRECT, EPS) | Class B | Diag. M (Pvt) Limited |
| MDIR-0008625 | Alpha-Amylase CC FS (Alpha-Amylase) | Class B | Nextek Healthcare |
| MDIR-0008626 | Pancreatic amylase CC FS (Pancreatic amylase) | Class B | Nextek Healthcare |
| MDIR-0008190 | LABKIT (AMYLASE-LQ | Class B | Miraj Corporation |
| MDIR-0005907 | MINDRAY Alpha Amylase Kit (IFCC Method) [a-AMY] | Class C | MR Medical Pakistan Pvt Ltd |
| MDIR-0004857 | Actoclean Perfect (Enzyme based liquid cleaner for medical instruments and endoscopes) Each 100g contains; Ethoxylated Alcohol… | Class B | Mezan International |
| MDIR-0002555 | DETRO Cid Enzyme (Enzyme (amylase,Lipase, Protease) Didecylmethylammoni um chloride, Benzalkonium Chloride, BIS (3-aminopropyl) dodecylamine) | Class C | 4A International |
| MDIR-0002556 | DETRO ACTIV (Peracetic Acid Powder, with enzyme amylase, Lipase, protease) | Class C | 4A International |
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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.