DRAP REGISTERED MEDICAL DEVICE
HBV Real-TM Quant DX (HBV Hepatitis B Virus Quantitative) V5-96/3FRT is registered with DRAP under number MDIR-0000550 as a Class D (high risk) medical device, imported. The listed holder is Global Marketing Services. Its listed renewal date (7 Nov 2024) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0000550 · the class is taken from DRAP's list for this number
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-00109
| Device | HBV Real-TM Quant DX (HBV Hepatitis B Virus Quantitative) V5-96/3FRT |
|---|---|
| Class | D |
| Listed holder | Global Marketing Services |
| Holder address | 111-B, Hali Road, Westridge 1, Rawalpindi., Godown: Same as above |
| Manufacturing site | M/s. Sacace Biotechnologies S.R.L. Via Scalabrini, 44, 22100, Como, Italy |
| Issued | 7 Dec 2019 |
| Renewal date | 7 Nov 2024 |
| Licence | ELI-00109 |
Specifications
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Screened 6 Oct 2026, 18:37 (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-0000258 | SaCycler-96 Real time PCR System Code: SC-96I | Class A |
| MDIE-0000294 | Gentier 96E (Real-Time PCR System) | Class A |
| MDIE-0000305 | Capillarys 3 OCTA Instrument [1245] | Class A |
| MDIE-0000306 | CAPILLARYS 3 TERA Instrument and Accessories [1246, 1248] | Class A |
| MDIE-0000315 | GeneRotex96 (Nucleic Acid Extractor) | Class A |
| MDIE-0000316 | Hologic Panther System [303095] | Class A |
| MDIE-0000331 | GeneXpert Instrument Systems [GX-I, GX-II, GX-IV, GX-XVI, GX-I R2, GX-II R2, GX-IV R2, GX-XVI R2, XPERTCHECK-CE-5] | Class A |
| MDIE-0000332 | Film Array Instrument System [Film Array Torch System [HTFA-ASY-0104] Film Array Torch Module (HTFA-SUB-0103) Film Array… | Class A |
| MDIE-0000333 | Prolystica Cleaning Chemistry (RESTORE Descaler & Neutralizing detergent) [1C45T6WR] | Class A |
| MDIE-0000334 | Bio Optica Slide Staining Sets [10-10, 10-20, 10-30, 10-33, 10-42] | Class A |
| MDIE-0000335 | Minicap Flex Piercing Instrument & Accessories (Capillary Electrophoresis Instrument) [1232] | Class A |
| MDIE-0000438 | PRE-Klenz (Instrument Transport Gel) [150377] | Class A |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0005215 | HBV DNA Real Time Quantitative 2.0 (Kit) [Code: AA206/48 Tests: 48 tests] | Class C | Abdullah Traders |
| MDIR-0005216 | HCV RNA Real Time Quantitative 3.0 (Kit) [Code: AA910/48 Tests: 48 tests] | Class C | Abdullah Traders |
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.