DRAP REGISTERED MEDICAL DEVICE
ROBO-GENE HBV DNA (PCR Quantification Kit 3.0) is registered with DRAP under number MDIR-0002695 as a Class D (high risk) medical device, imported. The listed holder is Chemical House. Its listed renewal date (2 Aug 2026) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0002695
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-00156
| Device | ROBO-GENE HBV DNA (PCR Quantification Kit 3.0) |
|---|---|
| Class | D |
| Listed holder | Chemical House |
| Holder address | 6-C Sikandar Malhi Road Canal Park, Gulberg-II, Lahore. |
| Manufacturing site | M/s AJ Roboscreen GmbH Hohmannstrasse 7m 04129, Leipsig, Germany |
| Issued | 3 Aug 2021 |
| Renewal date | 2 Aug 2026 |
| Licence | ELI-00156 |
Specifications
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Screened 5 Oct 2026, 11:04 (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-0000298 | Evolis Twin Plus Microplate Analyzer [93501] | Class A |
| MDIE-0001111 | Roboscreen Instant Virus RNA/DNA Kit (847-0259200602- 847-0259200603) | Class A |
| MDIE-0001268 | PR4100 Reader (94196/91587) | Class A |
| MDIE-0001996 | Bioplex 2200 Instrument [660-0000] (Immunoassay analyzer) | Class A |
| MDIR-0002280 | Monolisa HCV Ag-AB Ultra V2 Assay (cat # 72561, 72562) (EIA Microplate Format) Code: 2734000 | Class D |
| MDIR-0002674 | PLATELIA SARS-CoV-2 Total Ab Assay | Class C |
| MDIR-0002694 | Robe Gene HDV RNA Quantification Kit 2.0 | Class D |
| MDIR-0002696 | ROBO-GENE HCV RNA (PCR Quantification Kit 3.0) | Class D |
| MDIR-0002697 | Monolisa Anti HCV Plus version-3 Assay (EIA Microplate Format) [72340 (96 tests) 72341 (480 tests)] | Class D |
| MDIR-0003157 | D-10 Dual Program Reorder Pack [2200201 ] | Class B |
| MDIR-0003158 | D-100 HbA1c Reagents Diabetes Testing Reagent | Class B |
| MDIR-0003159 | Variant II Hb Testing System Diabetes Testing Reagent | Class B |
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.