DRAP REGISTERED MEDICAL DEVICE
SPECTRUM DIAGNOSTICS (Hematology-General Coagulation Tests) PT Recoplastin ISI 1.0 [624000, 624001, 62003, 624004 / 1 x 8ml, 6 x 4 ml, 6x 8 ml, 8 x 4ml] APTT Unicelin [626001, 626003, 626005 / 30 Tests, 160 Tests, 240 Test] is registered with DRAP under number MDIR-0009009 as a Class B (low to moderate risk) medical device, imported. The listed holder is Pakistani Trading Agencies. It is listed as valid until 11 Apr 2030.
Screening result
MDIR-0009009 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
That list covers manually issued licences only. Ask for a copy of the establishment licence.
| Device | SPECTRUM DIAGNOSTICS (Hematology-General Coagulation Tests) PT Recoplastin ISI 1.0 [624000, 624001, 62003, 624004 / 1 x 8ml, 6 x 4 ml, 6x 8 ml, 8 x 4ml] APTT Unicelin [626001, 626003, 626005 / 30 Tests, 160 Tests, 240 Test] |
|---|---|
| Class | B |
| Listed holder | Pakistani Trading Agencies |
| Holder address | 36 Lodge Road, Dooni Chand Street, Old Anarkali, Lahore |
| Manufacturing site | M/s Egyptian Company for Biotechnology - Spectrum Diagnostics Obour City Industrial Area, Block 20008 Piece 19 A, Po Box 30 18111 Cairo, Egypt |
| Issued | 12 Apr 2025 |
| Renewal date | 11 Apr 2030 |
Specifications
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Screened 6 Oct 2026, 01:31 (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.
| MDIR-0009007 | SPECTRUM DIAGNOSTICS (Immunochemistry-Tra nsport Protein) Microalbumin (MAU) Immunoturbidimetry [600 001 / 100 Tests] | Class B |
| MDIR-0009008 | SPECTRUM DIAGNOSTICS (Immunochemistry Rheumatoid Inflammatory Disease Marker) Antistreptolysin O Titre (ASOT) Latex [510 001, 510 002… | Class B |
| MDIR-0009010 | SPECTRUM DIAGNOSTICS (Immunochemistry Diabetes Assay) Hemoglobin A1c (HbA1c) Turbidimetric Immunoassay [602001-I , 602003-I/50 Tests, 100 Tests] | Class B |
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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.