FDA Registration
Active
🇫🇮 Finland
WALLAC OY
Reg #: 8043909
·
FEI: 3002808498
·
Expires 2026
Products
40
Proprietary Names
69
Establishment Types
2
Classifications
40
Registration Details
- Registration Name
- WALLAC OY
- Registration Number
- 8043909
- FEI Number
- 3002808498
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- MUSTIONKATU 6
- City
- TURKU Varsinais-Suomi
- Country
- FI
Regulatory Submissions
- 510(k) Number
- K081922
- PMA Number
- P970037
Owner / Operator
- Firm Name
- Revvity, Inc.
- Operator Number
- 9912035
- Address
- 77 4th Avenue
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
US Agent
- Business Name
- Revvity, Inc.
- Contact Name
- Daniel Castellanos
- Address
- 77 4th Avenue
- City
- Waltham
- State
- MA
- ZIP
- 02451
- Country
- US
- [email protected]
- Phone
- 973 5808347
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2022-08-19 |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | Class 1 | Clinical Chemistry | No | 2009-04-17 |
| Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | KQP | Class 2 | Clinical Chemistry | No | 2010-07-16 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2005-02-28 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2016-08-21 |
| Spinal Muscular Atrophy Newborn Screening Test System | QUE | Class 2 | Immunology | No | 2022-11-23 |
| Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System | PJI | Class 2 | Immunology | No | 2014-12-16 |
| Control, Hemoglobin, Abnormal | JCM | Class 2 | Hematology | No | 2021-11-19 |
| N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin | JNO | Class 1 | Clinical Chemistry | No | 2011-06-27 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2011-04-26 |
| Radioimmunoassay, Total Thyroxine | CDX | Class 2 | Clinical Chemistry | No | 2008-01-03 |
| Muscular Dystrophy Newborn Screening Test | QJE | Class 2 | Clinical Chemistry | No | 2019-12-20 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2022-07-11 |
| System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry | NQL | Class 2 | Clinical Chemistry | No | 2018-11-20 |
| Abnormal Hemoglobin Quantitation | GKA | Class 2 | Hematology | No | 2008-04-16 |
| Agglutination Method, Human Chorionic Gonadotropin | JHJ | Class 2 | Clinical Chemistry | No | 2008-02-29 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2010-03-11 |
| System, Test, Biotinidase | NAK | Class 2 | Clinical Chemistry | No | 2010-03-11 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2010-03-11 |
| Enzymatic Methods, Galactose | JIA | Class 1 | Clinical Chemistry | No | 2019-11-27 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2005-04-08 |
| Enzyme Immunoassay, Inhibin-A | NDR | Class 1 | Clinical Chemistry | No | 2015-03-09 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2009-09-08 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2009-09-08 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2012-05-21 |
| Enzyme Controls (Assayed And Unassayed) | JJT | Class 1 | Clinical Chemistry | No | 2007-12-19 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 1992-05-21 |
| ß-Galactocerebrosidase (Galc) Newborn Screening Test System | QCM | Class 2 | Clinical Chemistry | No | 2018-07-24 |
| Alpha-D-Glucosidase (Gaa) Newborn Screening Test System | PQU | Class 2 | Clinical Chemistry | No | 2018-07-24 |
| Acid-Sphingomyelinase (Asm) Newborn Screening Test System | QCL | Class 2 | Clinical Chemistry | No | 2018-07-24 |
| ß-Glucocerebrosidase (Gba) Newborn Screening Test System | PQV | Class 2 | Clinical Chemistry | No | 2018-07-24 |
| Alpha-L-Iduronidase (Idua) Newborn Screening Test System | PQT | Class 2 | Clinical Chemistry | No | 2018-07-24 |
| Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | PQW | Class 2 | Clinical Chemistry | No | 2018-07-24 |
| Kit, Test, Alpha-Fetoprotein For Neural Tube Defects | LOK | Class 3 | Unknown | No | 2007-12-19 |
| Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | JNB | Class 2 | Clinical Chemistry | No | 2007-12-19 |
| Mass Spectrometer, Clinical Use | DOP | Class 1 | Clinical Chemistry | No | 2017-09-06 |
| Radioimmunoassay, Estriol | CGI | Class 1 | Clinical Chemistry | No | 1995-03-30 |
| Shaker/Stirrer | JRQ | Class 1 | Clinical Chemistry | No | 2005-02-28 |
| Apparatus, Electrophoresis, For Clinical Use | JJN | Class 1 | Clinical Chemistry | No | 2005-10-27 |
| Block, Heating | JRG | Class 1 | Clinical Chemistry | No | 2005-02-28 |
Proprietary Names
AutoDELFIA Neonatal 17 a-OH-progesterone (B024-104, B024-112)
GSP Neonatal GALT Kit (3303-001U)
DELFIA Trio (1296-0070)
Panthera-Puncher 9 (2081-0010)
Infusence Infusion Pump (2040-0050)
DELFIA Dried Blood Spot Puncher (1296-071)
DELFIA Wash Concentrate (PN B117-100, 1244-114, 4010-0010)
DELFIA Enhancement Solution (B118-100, 1244-104, 1244-105)
DELFIA Diluent 2 (B131-100, B132-100, B138-100)
DELFIA Inducer (3304-0010)
GSP Wash Concentrate (4080-0010)
DELFIA Diluent 3 (4021-0010, 4022-0010)
Buffer M (4402-0010)
Eonis SCID-SMA Kit (3242-001U)
Eonis SCID-SMA Kit (3241-001U)
EnLite Neonatal TREC kit (3401-001U, 3402-001U, 3403-001U)
RESOLVE Hb FASC Control Kit (3412-0010)
AutoDELFIA Neonatal IRT kit (B005-204, B005-212)
GSP Neonatal Thyroxine (T4) kit (3302-001U)
AutoDELFIA Neonatal Thyroxine (T4) (B065-112)
DELFIA Neonatal Thyroxine (T4) kit (A065-110)
GSP Neonatal Creatine Kinase-MM kit (3311-001U)
Iduronate 2-sulfatase SIS (4400-0010)
LysoPC IS (4417-0010)
NeoBase Non-derivatized Assay Solutions (3041-0020)
NeoBase Non-derivatized MSMS kit (3040-001U)
NeoBase Succinylacetone Assay Solution (3042-0020)
Hb Elution Solution (3024-0010, 3025-0010)
JB-2 Staining System (FR-9367)
RESOLVE Hemoglobin kit (FR-9120, FR-9360, FR-9400)
AutoDELFIA hCG kit (B007-112)
Neonatal Biotinidase Kit (3018-0010, 3018-001B)
GSP Neonatal Biotinidase (3307-001U)
GSP® Neonatal Total Galactose kit (3309-002U)
MSMS Workstation Software (5002-0540)
Eonis Analysis Software (5020-1000)
AutoDELFIA Inhibin A kit (B064-112)
AutoDELFIA Inhibin A kit Level Calibrators (B064-112-P2)
GSP Instrument including software (2021-0010)
GSP Neonatal hTSH kit (3301-001U)
Chemagic Prepito D (2022-0020)
chemagic DNA CS200 kit (3207-0010)
chemagic 360-D (2024-0010)
Eonis DNA Extraction kit (3240-001U)
NeoBase Non-Derivatized MSMS Kit (3040-001U)
NeoBase Non-Derivatized Assay Solutions (3041-0020)
Neonatal GALT (NG-1100, NG-4100)
Neonatal Total Galactose (3029-0010)
DELFIA hLH Spec (A031-101)
NeoLSD MSMS kit (3093-004U)
NeoLSD MSMS kit (3093-001U)
AutoDELFIA instrument
AutoDELFIA hAFP kit (B079-212)
GSP Neonatal 17aOH progesterone kit (3305-001U)
Neonatal Phenylalanine (NP-1000, NP4000)
NeoBase 2 Non-derivatized MSMS Kit
QSight 225 MD UHPLC Screening System (2040-0030)
AutoDELFIA instrument (models 1297-014, 1297-0110, 1235-0110, 1235-5110, 1235-5220)
Victor D (1420-020, 1420-021)
AutoDELFIA Neonatal hTSH kit (B032-312)
DELFIA Neonatal hTSH kit (A032-310)
AutoDELFIA Unconjugated Estriol (uE3) (B095-101U, B095-112)
DELFIA Plate Shaker
NeoBase 2 Succinylacetone Assay Solution (3046-0010)
NeoBase 2 Non-derivatized MSMS kit (3044-001U)
NeoBase 2 Non-derivatized Assay Solutions (3045-0010)
GSP Neonatal IRT Kit (3306-001U)
Migele Gel Electrophoresis Unit (2118-0010)
TriNEST Microplate incubator and shaker (1296-0050)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device