Virgo HSV-2 Igg Elisa
FDA 510(k) K883281 · Electro-Nucleonics, Inc.
510(k) numberK883281
Submission
- Device name
- Virgo HSV-2 Igg Elisa
- Applicant
- Electro-Nucleonics, Inc.
Columbia, MD, US - Received
- August 3, 1988
- Decision date
- March 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GQO – Antisera, Cf, Herpesvirus Hominis 1,2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
Other 510(k)s with product code GQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883282 | Virgo HSV-1 Igg ElisaGQO · Traditional | Electro-Nucleonics, Inc. | 03/10/1989SE |
| K881261 | Bion HSV1-G or HSV2-G Test SystemGQO · Traditional | Bion Ent., Ltd. | 06/07/1988SE |
| K875366 | The Ddi Serodot Herpes Igg Test KitGQO · Traditional | Disease Detection International, Inc. | 05/23/1988SE |
| K871426 | Virogen HSV Antibody TestGQO · Traditional | Armkel, LLC | 10/15/1987SE |
| K861120 | The Golden Quad Test (HSV)GQO · Traditional | Microbiological Research Corp. | 02/02/1987SE |
| K854712 | Visible-Herpes TM Test SystemGQO · Traditional | Isolab, Inc. | 05/20/1986SE |
| K852782 | Hsvi - Igg Elisa-KitGQO · Traditional | Clinical Sciences, Inc. | 01/21/1986SE |
| K852781 | HSV2 - Igg Elisa-KitGQO · Traditional | Clinical Sciences, Inc. | 01/21/1986SE |
| K842663 | Anti-Herpes Simplex Virus Type 1 or 2GQO · Traditional | Amico Lab, Inc. | 12/06/1985SE |
| K842531 | Amizyme-Hsv Types 1 & 2 Test KitsGQO · Traditional | Amico Lab, Inc. | 12/06/1985SE |
More from Amico Lab, 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 |
| K883102 | Virgo (R) Cmv-Igg ElisaGQI · Traditional | 02/08/1989SE |
| 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 HSV-2 Igg Elisa cleared by the FDA?
Virgo HSV-2 Igg Elisa (K883281) received a 510(k) decision of Substantially Equivalent on March 10, 1989, 219 days after the submission was received.
What is the product code of K883281?
The FDA product code is GQO – Antisera, Cf, Herpesvirus Hominis 1,2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.