Alinity h-series WBC Reagent 07P7904 Alinity h-series Retic Reagent 07P8004 - DRAP MDIR-0004197 (Class B)

DRAP REGISTERED MEDICAL DEVICE

Alinity h-series WBC Reagent 07P7904 Alinity h-series Retic Reagent 07P8004 Alinity h-series HGB Reagent 07P8104 Alinity h-series Phosphate Buffer 07P8301 is registered with DRAP under number MDIR-0004197 as a Class B (low to moderate risk) medical device, imported. The listed holder is Abbott Laboratories(Pakistan) Ltd. It is listed as valid until 28 Nov 2027.

Screening result

Imported device, registered with DRAP as Class B (low to moderate risk)
MDIR-0004197 · the class is taken from DRAP's list for this number

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Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025

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Listed valid until 28 Nov 2027

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Holder has a DRAP import licence on file
ELI-00019

Device	Alinity h-series WBC Reagent 07P7904 Alinity h-series Retic Reagent 07P8004 Alinity h-series HGB Reagent 07P8104 Alinity h-series Phosphate Buffer 07P8301
Class	B
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, Finisklin Business Park, Sligo, Ireland
Issued	29 Nov 2022
Renewal date	28 Nov 2027
Licence	ELI-00019

Specifications

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Supplier of this device? Add specifications (free during launch)

Screened 5 Oct 2026, 14:45 (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

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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.