Medical device licence · 103897 · Class 2
VALENT AUTOMATED STAINING PLATFORM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed November 19, 2019; ended November 21, 2023. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 103897
- Licence holder
- Biocare Medical, LlcPacheco, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 19, 2019
- Ended
- November 21, 2023
- Devices covered
- 135
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- (GFAP{M})
- ADIPOPHILIN
- ALK [5A4]
- ALPHA-1-FETOPROTEIN (AFP)
- ARGINASE-1
- BCL-2
- BCL-6 [LN22]
- BETA-CATENIN
- CA 125
- CALCITONIN
- CALPONIN
- CALRETININ
- CARCINOEMBRYONIC ANTIGEN
- CD10
- CD117/C-KIT
- CD138
- CD1A [O10]
- CD20 [L26]
- CD23
- CD3 (P)
- CD3 T-CELL (M)
- CD3 [LN10]
- CD30 COCKTAIL
- CD33
- CD34
- CD4 (RM)
- CD56
- CD7
- CD79A
- CD8
- CD8 [C8/144B]
- CD99
- CDH17 (M)
- CDX2 (RM)
- CHROMOGRANIN A
- CK HMW + P63 + AMACR (RM)
- CK5/14 + P63 + CK7/18
- CK7
- CYCLIN D1
- CYTOKERATIN 18 (CK18)
- CYTOKERATIN 20 (CK20)
- CYTOKERATIN 5 (CK5)
- CYTOKERATIN 5/14 COCKTAIL
- CYTOKERATIN 5/6 (CK 5/6)
- CYTOKERATIN 7 (CK7)
- CYTOKERATIN HMW [34BETAE12]
- CYTOKERATIN LMW (8/18)
- DOG1
- E-CADHERIN
- E-CADHERIN (RM)
- ERG-2 (ERG + CD5)
- GATA-3
- HELICOBACTER PYLORI
- HMB45
- HMB45 + MART-1 + TYROSINASE
- HMW CK + P63 (BASAL CELL COCKTAIL)
- HUMAN CHORIONIC GONADOTROPIN (BETA)
- KAPPA (M) + LAMBDA (P)
- KAPPA LIGHT CHAIN [L1C1]
- KI-67
- KI-67 [MIB-1]
- LAMBDA LIGHT CHAIN [N10/2]
- LEUKOCYTE COMMON ANTIGEN (LCA) COCKTAIL
- MAMMAGLOBIN (M)
- MART-1 COCKTAIL
- MELAN A (M)
- MELANOMA COCKTAIL
- MUM-1
- MUSCLE SPECIFIC ACTIN (MSA)
- MYELOPEROXIDASE (P)
- MYOGENIN
- NAPSIN A
- NAPSIN A (RM)
- OCT-3/4
- P120 + E-CADHERIN
- P120 CATENIN
- P16 INK4A [BC42]
- P40 (M)
- P40 (P)
- P53
- P53 TUMOR SUPPRESSOR PROTEIN (M)
- P63
- P63 + CK5
- P63 + TRIM29
- PAN CYTOKERATIN PLUS [AE1/AE3+8/18]
- PAN CYTOKERATIN [AE1/AE3]
- PAN CYTOKERATIN [LU-5]
- PAN MELANOMA + KI-67
- PAN MELANOMA COCKTAIL-2 (MART-1 AND TYROSINASE)
- PAX5
- PAX8
- PAX8 (M)
- PD-1
- PD-1 (RM)
- PD-L1
- PROSTATE SPECIFIC ANTIGEN (PSA)
- PTEN (TUMOR SUPPRESSOR)
- S100 PROTEIN [15E2E2] (M
- S100P
- SMOOTH MUSCLE ACTIN (SMA)
- SMOOTHELIN
- SOX10 (M)
- SOX11 (M)
- SYNAPTOPHYSIN
- TERMINAL DEOXYNUCLEOTIDYL TRANSFERASE (TDT {P})
- TIA-1
- TTF-1
- TTF-1 [SPT24]
- TUMOR ASSOCIATED GLYCOPROTEIN [B72.3]
- TYROSINASE
- UROPLAKIN II
- UROPLAKIN II + UROPLAKIN III
- UROPLAKIN III
- VAL AQUA RINSE, 20X
- VAL AR-HI PH, 5X
- VAL AR-LO PH 5X
- VAL BACKGROUND BLOCK
- VAL DAB CHROMOGEN KIT
- VAL DEPAR
- VAL FAST RED CHROMOGEN KIT
- VAL HEMATOXYLIN
- VAL PEROXIDASE BLOCK
- VAL PLEX 1
- VAL PLEX 2
- VAL UNIVERSAL NEGATIVE CONTROL
- VAL WASH BUFFER, 20X
- VAL ZYME PRONASE KIT
- VAL ZYME TRYPSIN KIT
- VAL-TECT HRP DETECTION KIT
- VAL-TECT MOUSE AP POLYMER
- VAL-TECT MOUSE HRP POLYMER
- VAL-TECT RABBIT AP POLYMER
- VAL-TECT UNIVERSAL HRP DETECTION KIT
- VALENT AUTOMATED STAINING PLATFORM
- VALPREP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.