Enhance Sperm Wash w/ Gentamicin - 1-(500ml) Enhance Sperm Wash w/ Gentamicin
2018-04-20
Vitrolife Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2031824 | 3002757762 | Vitrolife Inc. | 1 | Y | 2026-01-01 | 4940 Carroll Canyon Rd Ste 100 San Diego CA US 92121 |
| 3003274090 | 3003274090 | Vitrolife Inc. | 1 | Y | 2026-01-01 | 3601 South Inca Street Englewood CO US 80110 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 122953 | 1253113208 | K993140 | WATER FOR TISSUE CULTURE, MODELS 1500 | MTW | 2000-08-02 |
| 122953 | 1782728448 | K991322 | ENHANCE-S PLUS | MQL | 1999-07-26 |
| 122953 | 1833772777 | K991104 | MICROTOOLS | MQH | 1999-07-19 |
| 122953 | 1753469065 | K871726 | OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) | CEP | 1987-07-27 |
| 122953 | 1574232204 | K030117 | ENHANCE SPERM FREEZE | MQL | 2003-03-20 |
| 122953 | 1152787100 | K030116 | ENHANCE-S PLUS H | MQL | 2003-02-12 |
| 122953 | 1036905112 | K023717 | SPERM WASH MEDIUM WITH GENTAMICIN | MQL | 2002-12-13 |
| 122953 | 1354755226 | K023655 | ENHANCE HTF MEDIUM WITH HEPES | MQL | 2002-12-13 |
| 96900 | 1008060616 | ||||
| 96900 | 1252259766 | ||||
| 96900 | 1288380364 | ||||
| 96900 | 1320917841 | ||||
| 122953 | 1354507925 | ||||
| 96900 | 1362400525 | ||||
| 96900 | 1435005007 | ||||
| 96900 | 1440398204 | ||||
| 96900 | 1464170195 | ||||
| 96900 | 1522511712 | ||||
| 96900 | 1623465599 | ||||
| 96900 | 1623944338 | ||||
| 96900 | 1747130039 | ||||
| 96900 | 1951898948 | ||||
| 122953 | 1977537822 |
Product Codes Associated With Registrations#
GUDID#
Enhance Water for Tissue Culture - Enhance Water for Tissue Culture, 1.5 Liter
2018-04-23
Handling Pipette - 15530
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Handling Pipette - 15534
2021-09-03
Handling Pipette - 15535
2021-09-03
Handling Pipette - 15536
2021-09-03
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2021-09-03
Handling Pipette - 15538
2021-09-03
Handling Pipette - 15530
2021-09-03
Handling Pipette - 15531
2021-09-03
Handling Pipette - 15532
2021-09-03
Handling Pipette - 15533
2021-09-03
Handling Pipette - 15534
2021-09-03
Handling Pipette - 15535
2021-09-03
Handling Pipette - 15536
2021-09-03
Handling Pipette - 15537
2021-09-03
Handling Pipette - 15538
2021-09-03
Biopsy Pipette - 15145
2020-07-13
Biopsy Pipette - 15145
2020-07-13
ICSI Pipette - 15448
2020-04-28
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ICSI Pipette - 15451
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Leucoscreen Plus Test Kit - Leucoscreen Plus Test Kit, 20 tests per kit
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2020-04-28
ICSI Pipette - 15453
2020-04-28
OvuQuick Ovulation Predictor Test - 15100
2016-09-23
OvuQuick Ovulation Predictor Test - 15101
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ICSI Pipette - 15430
2016-09-23
Enhance-S Plus - 6-(12.5ml/90%) & 6-(12.5ml/45%)
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Enhance Sperm Wash - 12-(12ml) Sperm Wash Modified HTF Medium
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Gynosampler - 15099
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Enhance Sperm Wash with Gentamicin - 12-(12ml) Sperm Wash Modified HTF Medium w/Gentamicin
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ICSI Pipette - 15433
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ICSI Pipette - 15437
2016-09-23