DRAP REGISTERED MEDICAL DEVICE
Hemoglobin Test kit for Laffinite II (HbA1c Reagent kit) [500 Tests/kit] is registered with DRAP under number MDIR-0008424 as a Class B (low to moderate risk) medical device, imported. The listed holder is Bio Sphere Marketing. It is listed as valid until 22 Mar 2030.
Screening result
MDIR-0008424 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00922
| Device | Hemoglobin Test kit for Laffinite II (HbA1c Reagent kit) [500 Tests/kit] |
|---|---|
| Class | B |
| Listed holder | Bio Sphere Marketing |
| Holder address | H.No.02, St No. 04, Adjacent to the best grammar School, Park Town, Chungi Amar Sidhu, Lahore |
| Manufacturing site | M/s AE HEALTH LIMITED Floor 11, Building 1B, BTR Technology Park, Longtian Street, Pingshan District, Shenzhen, China |
| Issued | 23 Mar 2025 |
| Renewal date | 22 Mar 2030 |
| Licence | ELI-00922 |
Specifications
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Screened 6 Oct 2026, 07:22 (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-0000947 | Laffinite II HbA1c Analyzer Hemoglobin Analyzer HPLC Based | Class A |
| MDIE-0000948 | AUDICOM AC6601 HbA1c Analyzer (HbA1c Analyzer Model AC6601) | Class A |
| MDIE-0001341 | EH8300 Hematology Analyzer (Automatic Hematology Analyzer) | Class A |
| MDIR-0009089 | HbA1c Kit Audicom (HbA1c Kit) | Class B |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0009573 | EDiagnosis Hemoglobin A1c (HbA1c) Test Kit | Class B | Sure Bio Diagnostics & Pharmaceuticals |
| MDIR-0009334 | V-CHEK Hemoglobin A1c (HbA1c) Rapid Test Kit [5257C4X025, 5257C4X050] | Class B | Sure Bio Diagnostics & Pharmaceuticals |
| MDIR-0009010 | SPECTRUM DIAGNOSTICS (Immunochemistry Diabetes Assay) Hemoglobin A1c (HbA1c) Turbidimetric Immunoassay [602001-I , 602003-I/50 Tests, 100 Tests] | Class B | Pakistani Trading Agencies |
| MDIR-0008968 | D-10 Hemoglobin testing system | Class B | Chemical House |
| MDIR-0008176 | INST-ANSWER Hemoglobin Test Strips | Class B | Mian Scientific Corporation (Pvt) Ltd. |
| MDIR-0007598 | BioHerm's Glycohemoglobin Test Kit | Class C | Mian Scientific Corporation (Pvt) Ltd. |
| MDIR-0005638 | HemoSmart GOLD (Hemoglobin Test Strips) | Class C | Taj Diagnostics |
| MDIR-0005590 | CERTEZA Hemoget (Hemoglobin Test Strips) [HS-101] | Class C | RHS International |
| MDIR-0003160 | D-100 Hemoglobin Testing System [HbA1C Quantification] | Class B | Chemical House |
| MDIR-0003161 | Variant II Hemoglobin Testing System [HbA1C Quantification] | Class B | Chemical House |
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.