Manufacturer

Biochemical Diagnostics

United StatesLegal entities : Biochemical Diagnostics, Inc

Markets : Belgium · Netherlands · United States

Approvals : United States (FDA) – 510(k) : 2 · class I · latest in 2016 · see on the FDA website

EU representative : Advena Limited (Malta)

Website quality@biochemicaldiagnostics.com

1 category, 173 models including 173 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Devices for samples analyses - other	W05039099	9 PANEL -/+ 25%, 5ML KITBOX 1800290798/79 9 PANEL, CUTOFF, 5mL 1900290898/79 AU/NZ SKREEN, Cutoff +50%, 20mL 1948220098/79 AU/NZ SKREEN, Cutoff +50%, 5mL 1948020098/79 AU/NZ SKREEN, Cutoff -50%, 20mL 1948110098/79 168 others AU/NZ SKREEN, Cutoff -50%, 5mL 1948010098/79 AUNZS19 Cutoff +50%, 20mL 1810015798/79 AUNZS19 Cutoff +50%, 5mL 1810015498/79 AUNZS19 Cutoff -50%, 20mL 1810015698/79 AUNZS19 Cutoff -50%, 5mL 1810015398/79 Buprenorphine 15ng/mL, 5mL 1947000998/79 Buprenorphine 5ng/mL, 5mL 1947000898/79 Combo-A, 3X Cutoff, 20mL 1800309298/79 Combo-A, 3X Cutoff, 6x20mL 18003092-6pk98/79 Combo-A, Cutoff +50%, 20ml 1800309198/79 Combo-A, Cutoff +50%, 6x20mL 18003091-6pk98/79 Combo-A, Cutoff -50%, 20mL 1800309098/79 Combo-A, Cutoff -50%, 6x20mL 18003090-6pk98/79 Combo-H, +50%, 20ml 1800274398/79 Combo-H, 3X Cutoff, 20mL 1800284498/79 Combo-H, 3X Cutoff, 6x20mL 18002844-6pk98/79 Combo-H, Cutoff +50%, 6x20mL 18002743-6pk98/79 Combo-H, Cutoff -50%, 20mL 1800284298/79 Combo-H, Cutoff -50%, 6x20mL 18002842-6pk98/79 Combo-U, 3X Cutoff, 20mL 1800308998/79 Combo-U, 3X Cutoff, 6x20mL 18003089-6pk98/79 Combo-U, Cutoff +50%, 20mL 1800308898/79 Combo-U, Cutoff +50%, 6x20mL 18003088-6pk98/79 Combo-U, Cutoff -50%, 20mL 1800308798/79 Combo-U, Cutoff -50%, 6x20mL 18003087-6pk98/79 CONFIRM 3, +25%, 50mL 1958212598/79 CONFIRM 3, -60%, 50mL 1958204098/79 CONFIRM 3, Cutoff -25%, 50mL 1958202598/79 CONFIRM 3, CUTOFF, 50mL 1958200098/79 CONFIRM 4 CUTOFF -25%, 10x50mL 19582026-10pk98/79 CONFIRM 4, CUTOFF +25%, 10x50mL 19582126-10pk98/79 CONFIRM 4, Cutoff -60%, 10x50mL 19582041-10pk98/79 Confirm 4, Cutoff 10x50mL 19582002-10pk98/79 COTININE URINE CONTROL 2x5mL Kitbox 70201898/79 Cotinine, 5ml in baggie 400ng/ml 1820001998/79 CP-OF Panel, 3X Cutoff, 20mL 1810015198/79 CP-OF Panel, Cutoff +50%, 20mL 1810015098/79 CP-OF Panel, Cutoff -50%, 20mL 1810014998/79 CSCQ Specimen 1 1800844598/79 CSCQ Specimen 2 1800844698/79 CSCQ Specimen 3 1800844798/79 CSCQ Specimen 4 1800844898/79 Custom Oral Fluid, AU/NZ Cutoff +50%, 5mL 1810000198/79 Custom Oral Fluid, Negative, 5mL 1810000098/79 DOA SCREEN Cutoff +25% 6x20 mL pk 180011V-6pk98/79 DOA SCREEN Cutoff -25% 6x20 mL pack 180010V-6pk98/79 DOA SKREEN-H 2x10mL 70200298/79 DOA-SKREEN POSITIVE CONTROL, 6x10mL 19003020-6PK98/79 DOA-SKREEN URINE CONTROL KITBOX 70200198/79 DOA-SKREEN-H POSITIVE CONTROL, 6x10mL 19003030-6PK98/79 Drug Evaluation Panel 1-20,3ml 2665798/79 ETHYL GLUCURONIDE 1000 ng/mL 2x20mL 19900100-2pk98/79 ETHYL GLUCURONIDE 250ng/mL 2x20mL 19900025-2pk98/79 ETHYL GLUCURONIDE 500ng/mL 2x20mL 19900050-2pk98/79 Eurofins QC1, 25mL 1800309398/79 Eurofins QC3, 25mL 1800327898/79 GC/MS CUTOFF +25%, 10x50mL 19332501-10pk98/79 GC/MS CUTOFF -25%, 10x50mL 19332001-10pk98/79 GC/MS CUTOFF 19330000-10pk98/79 GC/MS-H CUTOFF +25%, 10x50mL 19572753-10pk98/79 GC/MS-H CUTOFF -25%, 10x50mL 19572251-10pk98/79 GC/MS-H CUTOFF 10x50mL 19572502-10pk98/79 GCMS-H Control, Cutoff -60%, 50mL 1957225698/79 hCG 4mL Kit Neg/Pos dropper 1803036798/79 hCG Low positive / Negative URINE 2x5mL Kitbox 1800315598/79 HCG URINE CONTROL Negative/Low Positive 2x4mL 70201298/79 HCG URINE CONTROL Negative/Low Positive 2x4mL KITBOX 70201398/79 JWH-018 5-PENTANOIC ACID URINE CONTROL KITBOX 70201798/79 JWH-073 4-Butanoic Acid, 100ng/mL, 5mL 1900096098/79 l-Cotinine 400ng/mL, 5mL 1900010298/79 MDMA OXY & BUP, Cutoff +50%, 5mL 1947001198/79 MDMA OXY & BUP, Cutoff -50%, 5mL 1947001098/79 MDMA, OXY, BUP, Cutoff +50%, 10x5mL 19470011-10pk98/79 MDMA, OXY, BUP, Cutoff -50%, 10x5mL 19470010-10pk98/79 MDMA/6-MAM, -50%, 20mL 1800753098/79 MDMA/6-MAM, 2X Cutoff, 20mL 1800771698/79 NEG & SS(LM)MOB, 2x20ml Neg/Pos kitbox 82000098/79 Negative 2x5ml kitbox 1800514398/79 Negative Urine Control 10x50mL 19227000-10pk98/79 Negative Urine Control 10x5mL 19700000-10pk98/79 Negative Urine Control 6x10mL 19000010-6pk98/79 Negative Urine Control 6x20mL 19223011-6PK98/79 Negative Urine Control with Stabilizer, 1L 1947001298/79 Negative Urine Control with Stabilizer, 500mL 1947000698/79 Negative Urine Control, 1L 1922701098/79 Negative Urine Control, 500mL 1922700598/79 NORFENTANYL 50ng/mL 2x5mL KITBOX 70201698/79 Oral Fluid Control, Neg/3X POS, 2x20mL 70203098/79 ORAL-SKREEN Negative with Stabilizer, 500mL 2020020098/79 ORAL-SKREEN NEGATIVE, 20mL 2020010198/79 ORAL-SKREEN NEGATIVE, 500mL 2020010098/79 ORAL-SKREEN NEGATIVE, 6x20mL 20200101-6pk98/79 ORAL-SKREEN, 2X Cutoff, 20mL 2020010898/79 ORAL-SKREEN, 3X Cutoff, 20mL 2020010998/79 ORAL-SKREEN, 3X Cutoff, 6x20mL 20200109-6pk98/79 ORAL-SKREEN, Cutoff +50%, 20mL 2020010798/79 ORAL-SKREEN, Cutoff -50%, 20mL 2020010398/79 OXY/MDMA/EDD -50%, 20mL 1800249098/79 OXY/MDMA/EDDP+50 20mL 1800249198/79 PREGNANCY-SKREEN hCG Liquid Control Serum -/+ Low Positive 2x4mL 70203298/79 PREGNANCY-SKREEN hCG Liquid Control Serum -/+ 2x4mL 70203398/79 SERIES III 3X CUTOFF 6x20mL 19437908-6pk98/79 SERIES III CUTOFF +25% 6x20mL 19437756-6pk98/79 SERIES III CUTOFF -25% 6x20mL 19437252-6pk98/79 SERIES IV CUTOFF +25% 6x20mL 19447756-6pk98/79 SERIES IV 3X Cutoff 6x20mL 19447908-6pk98/79 SERIES IV CUTOFF -25% 6x20mL 19447252-6pk98/79 SERIES IV-H 3X Cutoff 6x20mL 19544908-6pk98/79 SERIES IV-H CUTOFF -25%, 6x20mL 19544252-6pk98/79 SERIES IV-H CUTOFF+25%, 6x20mL 19544756-6pk98/79 SERIES IV-H, Cutoff +25%, 20mL 1954475698/79 SERIES IV-H, Cutoff -25%, 20 mL 1954425298/79 SERIES IX 3X Cutoff, 20mL 1949990898/79 SERIES IX, Cutoff +25%, 20mL 1949975698/79 SERIES IX, Cutoff +25%, 6x20mL 19499756-6pk98/79 SERIES IX, CUTOFF -25% 6x20mL 19499252-6pk98/79 SERIES IX, Cutoff -25%, 20mL 1949925298/79 SERIES IX, CUTOFF 3X, 6x20mL 19499908-6pk98/79 SERIES V 3X Cutoff 6x20mL 19458908-6pk98/79 SERIES V CUTOFF +25% 6x20mL 19458756-6pk98/79 SERIES V CUTOFF -25% 6x20mL 19458252-6pk98/79 SERIES V w TCA,+25%, 20ml 1800770198/79 SERIES VI CUTOFF +25% 6x20mL 19466756-6pk98/79 SERIES VI CUTOFF -25% 6x20mL 19466252-6pk98/79 SERIES VI 3X CUTOFF, 6x20mL 19466908-6pk98/79 SERIES X-H, 3X CUTOFF, 6x20mL 19601908-6pk98/79 SERIES X-H, CUTOFF +25% 6x20mL 19601056-6pk98/79 SERIES X-H, CUTOFF -25% 6x20mL 19601052-6pk98/79 SERIES XV-H 3X CUTOFF 6x20mL 19601059-6pk98/79 SERIES XV-H CUTOFF +25% 6x20mL 19601058-6pk98/79 SERIES XV-H CUTOFF -25% 6x20mL 19601057-6pk98/79 Specialty Diagnostix Panel 1, 5mL 1800777498/79 Specialty Diagnostix Panel 2, 5mL 1800775198/79 SSHMOB 2X, 2x5ml kitbox 1800514498/79 SSHMOBE with BUTALBITAL 2x20ml 82000198/79 SSHMOBE with Butalbital 3X 100mL 1800828498/79 SSHMOBE with Butalbital Cutoff +50%, 20mL 1800832798/79 SSHMOBE with Butalbital Cutoff -50%, 20mL 1800282498/79 SSMOB, +50%, 50mL 1800766298/79 SSMOB, -50%, 50mL 1800766498/79 SSMOB, 3X, 50mL 1800766098/79 STAT-SKREEN 17 URINE CONTROL 2x10mL 70200398/79 STAT-SKREEN 17H, 2x10mL 70200498/79 STAT-SKREEN Cutoff, 20mL 1947005698/79 Stat-Skreen with low COC/OPI/METH, cutoff +50% 20mL 1800122998/79 STAT-SKREEN with low COC/OPI/METH, cutoff -50%, 20 mL 1800122898/79 STAT-SKREEN with MDMA, OXY & BUP 2X CUTOFF POSITIVE, 10x5mL 19001066-10pk98/79 STAT-SKREEN with MDMA, OXY & BUP 2x20ML KITBOX 70202898/79 STAT-SKREEN with MDMA, OXY & BUP, POSITIVE CONTROL 6x20mL 19002066-6PK98/79 STAT-SKREEN WITH MDMA, OXY, & BUP, 2x5mL 70201498/79 STAT-SKREEN, 3X Cutoff, 20mL 1947005598/79 STAT-SKREEN, Cutoff +25%, 20mL 1947005398/79 STAT-SKREEN, Cutoff +50%, 20mL 1947005198/79 STAT-SKREEN, Cutoff -25%, 20mL 1947005498/79 STAT-SKREEN, Cutoff -50%, 20mL 1947005298/79 STAT-SKREEN-H 3X with MDMA, OXY, BUP & EDDP, 100mL 1800405698/79 STAT-SKREEN-H with MDMA, OXY & BUP 2x20mL KITBOX 70202998/79 STAT-SKREEN-H with MDMA, OXY & BUP 2x5mL 70201598/79 STAT-SKREEN-H with MDMA, OXY & BUP, POSITIVE CONTROL 10x5ML 19001081-10PK98/79 STAT-SKREEN-H with MDMA, OXY & BUP, POSITIVE CONTROL 6x20mL 19002081-6PK98/79 STAT-SKREEN-H, 3X Cutoff, 20mL 1947007598/79 STAT-SKREEN-H, Cutoff +25%, 20mL 1947007298/79 STAT-SKREEN-H, Cutoff +50%, 20mL 1947007098/79 STAT-SKREEN-H, Cutoff -25% 20mL 1947007398/79 STAT-SKREEN-H, Cutoff -50%, 20mL 1947007198/79 STAT-SKREEN17 POSITIVE CONTROL, 6x10mL 19003066-6PK98/79 STAT-SKREEN17H URINE POSITIVE CONTROL, 6x10mL 19003081-6PK98/79 THC 1000ng, 100mL 1800045498/79	– 98/79	EUDAMED record Report an error

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