Primary Device ID | 00868586000285 |
NIH Device Record Key | 50e1b68e-1acb-48f5-a772-f3b6ec3ccd47 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | General Purpose Reagent Delayed Semen Analysis Media |
Version Model Number | PPM |
Company DUNS | 189222334 |
Company Name | Quest Diagnostics |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00868586000285 [Primary] |
PPM | General Purpose Reagent |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-19 |
Device Publish Date | 2023-07-11 |
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00868586000261 - HairCheck-DT (THC) Exempt | 2023-07-19 HairCheck-DT (THC) is an ELISA test kit used for qualitative detection of THC-COOH in head hair with a cutoff of 1.0 pg/mg of ha |
00868586000285 - General Purpose Reagent Delayed Semen Analysis Media | 2023-07-19DSAM Delayed Semen Analysis Media (Preservative media 150 µl) For Laboratory Use Only. INTENDED USE: The Delayed Semen Analysis Media (DSAM) is intended to be used at the direction of a health care professional for a patient to collect their own semen specimen for testing by a clinical laboratory. |
00868586000285 - General Purpose Reagent Delayed Semen Analysis Media | 2023-07-19 DSAM Delayed Semen Analysis Media (Preservative media 150 µl) For Laboratory Use Only. INTENDED USE: The Delayed Semen Analys |