Primary Device ID | 00863840000254 |
NIH Device Record Key | 04a6fb18-5ac0-4b00-bdd8-770addffa1dd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AmplideX Fragile X Dx & Carrier Screen Kit |
Version Model Number | 49591 |
Catalog Number | 49591 |
Company DUNS | 622988330 |
Company Name | ASURAGEN, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00863840000254 [Primary] |
OYV | Inherited Nucleotide Repeat Disorder Dna Test |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-04-15 |
Device Publish Date | 2020-04-07 |
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