Virgo (R) Cmv-Igg Elisa
FDA 510(k) K883102 · Electro-Nucleonics, Inc.
510(k) numberK883102
Submission
- Device name
- Virgo (R) Cmv-Igg Elisa
- Applicant
- Electro-Nucleonics, Inc.
Columbia, MD, US - Received
- July 22, 1988
- Decision date
- February 8, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GQI – Antiserum, Cf, Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
Other 510(k)s with product code GQI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952254 | Enzyme Linked Immunoabsorbent Assay, CytomegalovirusGQI · Traditional | Pyramid Biological Corp. | 11/16/1995SE |
| K951800 | CMV Igg Human Serum ControlsGQI · Traditional | Pyramid Biological Corp. | 11/16/1995SE |
| K942171 | CMV Early Antigen TestGQI · Traditional | Neogenex | 06/30/1994SE |
| K875159 | Detectadot System 2000 CMV Igg TestGQI · Traditional | Gull Laboratories, Inc. | 05/06/1988SE |
| K863488 | Enzygnost Anti-Cmv Igg TestGQI · Traditional | Behring Diagnostics, Inc. | 07/20/1987SE |
| K864420 | CMV MicroassayGQI · Traditional | Diamedix Corp. | 02/02/1987SE |
| K861123 | The Golden Quad Test (CMV)GQI · Traditional | Microbiological Research Corp. | 02/02/1987SE |
| K862705 | Cytomegalovirus Igg Eia Test KitGQI · Traditional | Labsystems, Inc. | 10/01/1986SE |
| K853989 | Cor Dot CMVGQI · Traditional | Cordis Corp. | 06/13/1986SE |
| K860493 | Cytotech CMV Igg EiaGQI · Traditional | Cytotech, Inc. | 05/20/1986SE |
More from Cytotech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K893718 | Deltatest (R) Lipase IICET · Traditional | 09/28/1989SE |
| K883670 | Serological Test Kit for Igg Anti. Epstein-Barr ViGNP · Traditional | 04/28/1989SE |
| K883427 | Virgo(R) Vzv-Igg ElisaGQX · Traditional | 03/10/1989SE |
| K883282 | Virgo HSV-1 Igg ElisaGQO · Traditional | 03/10/1989SE |
| K883281 | Virgo HSV-2 Igg ElisaGQO · Traditional | 03/10/1989SE |
| K884784 | Virgo(R) Microwell Alt AssayCKD · Traditional | 12/29/1988SE |
| K883206 | Lactate Dehydrogenase LDHCFJ · Traditional | 09/09/1988SE |
| K883205 | Altlts Alanine Amino Transferase AltCKA · Traditional | 09/09/1988SE |
Questions and answers
When was Virgo (R) Cmv-Igg Elisa cleared by the FDA?
Virgo (R) Cmv-Igg Elisa (K883102) received a 510(k) decision of Substantially Equivalent on February 8, 1989, 201 days after the submission was received.
What is the product code of K883102?
The FDA product code is GQI – Antiserum, Cf, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.